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Diagnostic Equipment

🏥 Medical Devices • 6,627 recalls

Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.

Abbott Gmbh & Co. KG

Class I - Dangerous

Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.

Apr 15, 2019 Diagnostic Equipment Nationwide View Details →

IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

Philips North America

Class I - Dangerous

The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .

Mar 28, 2019 Diagnostic Equipment Nationwide View Details →

IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

Philips North America

Class I - Dangerous

The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .

Mar 28, 2019 Diagnostic Equipment Nationwide View Details →

Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. Device Description: The AXS Infinity LS Plus Long Sheath is a single lumen, flexible, variable stiffness long sheath with an 0.091 inch inner diameter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Infinity LS Plus Long Sheath shaft has a 10 cm lubricious coating at the distal end to reduce friction during use. The inner lumen of the AXS Infinity LS Plus Long Sheath is compatible with 6F or smaller catheters. Each package includes one AXS Infinity LS Plus Long Sheath (INC- 11196-70, INC-11196-80, or INC-11196-90), one Dilator, and one hemostasis valve. Dimensions of the AXS Infinity LS Plus Long Sheath are included on the individual device label.

Stryker Neurovascular

Class I - Dangerous

A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.

Apr 18, 2019 Diagnostic Equipment Nationwide View Details →

IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

Philips North America

Class I - Dangerous

The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .

Mar 28, 2019 Diagnostic Equipment Nationwide View Details →

Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

Abbott Gmbh & Co. KG

Class I - Dangerous

Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.

Apr 5, 2019 Diagnostic Equipment Nationwide View Details →

Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications

NeuroLogica

Class I - Dangerous

Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.

May 6, 2019 Diagnostic Equipment Nationwide View Details →

Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

K2M

Class I - Dangerous

The products are mislabeled.

Apr 18, 2019 Diagnostic Equipment View Details →

Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

K2M

Class I - Dangerous

The products are mislabeled.

Apr 18, 2019 Diagnostic Equipment View Details →

UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC

Beckman Coulter

Class I - Dangerous

Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.

Jul 30, 2018 Diagnostic Equipment Nationwide View Details →

CHOL+HDL+GLU test strips, REF 2412

Polymer Technology Systems

Class I - Dangerous

Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed

Jan 16, 2019 Diagnostic Equipment Nationwide View Details →

UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC

Beckman Coulter

Class I - Dangerous

Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.

Jul 30, 2018 Diagnostic Equipment Nationwide View Details →

Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

Polymer Technology Systems

Class I - Dangerous

Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

Jan 16, 2019 Diagnostic Equipment Nationwide View Details →

MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick and accurate alignment with the patient and secure positive or negative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion. Indications: The MoniTorr ICP system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF inpatients with infected CSF shunts, and to monitor ICP.

Integra LifeSciences

Class I - Dangerous

The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

Apr 8, 2019 Diagnostic Equipment Nationwide View Details →

LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached. Indications: The LimiTorr system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.

Integra LifeSciences

Class I - Dangerous

The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

Apr 8, 2019 Diagnostic Equipment Nationwide View Details →

OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical environment. No special training is required but a review of the Safety Instructions is important for the safety of the operator and patient.

Oakworks

Class I - Dangerous

Table assembly error with incorrect actuators for the lateral and longitudinal table movements

May 2, 2019 Diagnostic Equipment Nationwide View Details →
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