🔍 RecallPedia
🔬

Diagnostic Equipment

🏥 Medical Devices • 6,627 recalls

Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.

Philips Medical Systems North America

Class I - Dangerous

A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated b

Feb 28, 2014 Diagnostic Equipment Nationwide View Details →

FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. Intended to monitor blood glucose from samples taken from the body. IVD use only,

Abbott Diabetes Care

Class I - Dangerous

Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.

Feb 19, 2014 Diagnostic Equipment Nationwide View Details →

Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.

Philips Medical Systems North America

Class I - Dangerous

A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by

Feb 28, 2014 Diagnostic Equipment Nationwide View Details →

Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿¿ 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

Lin-Zhi International

Class I - Dangerous

Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.

Feb 6, 2014 Diagnostic Equipment View Details →

Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

GE Healthcare

Class I - Dangerous

Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. N

Feb 7, 2014 Diagnostic Equipment Nationwide View Details →

GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications. The Innova 3100 system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, and optionally, rotational and angiography procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications. A new tilt table will support performing procedures like CO2 studies, Venography. The Digital Fluoroscopic Imaging System with Bolus Chasing option is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention; the option Bolus enables to perform subtraction angiography of lower limbs. This device is not intended for mammography applications. The Innova 2100-IQ system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures, and optionally, rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications. For Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100 IQ, Innova 2100IQ with Innova 3T Option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova CT is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. Innova CT is intended for imaging bone and soft tissues as well as other internal body structures. Innova CT is not intended for mammography applications. For Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100 IQ, Innova 2100IQ with Innova 3D or InnovaSpin option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications. InnovaSpin is a software option that permits fast spin rotational angiography. It is not intended for mammography applications. :

GE Healthcare

Class I - Dangerous

GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue.

Dec 11, 2013 Diagnostic Equipment Nationwide View Details →

VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles.

Steris

Class I - Dangerous

STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.

Dec 19, 2013 Diagnostic Equipment Nationwide View Details →

Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.

Mindray DS USA, Inc.

Class I - Dangerous

Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindray¿s V-Series Monitor. Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack.

Jan 8, 2014 Diagnostic Equipment Nationwide View Details →

GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

GE Healthcare

Class I - Dangerous

Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. N

Feb 7, 2014 Diagnostic Equipment Nationwide View Details →

G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Smiths Medical ASD

Class I - Dangerous

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Nov 22, 2013 Diagnostic Equipment Nationwide View Details →

Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

Philips Medical Systems

Class I - Dangerous

When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.

Feb 18, 2014 Diagnostic Equipment Nationwide View Details →

G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x 1 needle Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Smiths Medical ASD

Class I - Dangerous

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Nov 22, 2013 Diagnostic Equipment Nationwide View Details →

4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Smiths Medical ASD

Class I - Dangerous

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Nov 22, 2013 Diagnostic Equipment Nationwide View Details →

4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Smiths Medical ASD

Class I - Dangerous

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Nov 22, 2013 Diagnostic Equipment Nationwide View Details →

VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

Accumetrics

Class I - Dangerous

Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.

Feb 13, 2014 Diagnostic Equipment Nationwide View Details →

4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Smiths Medical ASD

Class I - Dangerous

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Nov 22, 2013 Diagnostic Equipment Nationwide View Details →

G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Smiths Medical ASD

Class I - Dangerous

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Nov 22, 2013 Diagnostic Equipment Nationwide View Details →
← Back to All Medical Devices Recalls