Class I - Dangerous
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Class I - Dangerous
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! have a software defect which affect data accuracy.
Belt clip may become detached causing electronic components to be exposed.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Siemens Healthcare Diagnostics
Class I - Dangerous
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
Omega Medical Imaging
Class I - Dangerous
Elevating Monitor Suspension separated from the lifting column bracket
There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.
Class I - Dangerous
The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use. The replacement is intended to prevent risk of electric shock.
e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
Siemens Medical Solutions USA
Class I - Dangerous
"We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of the patient positioning instructions for your e.cam or Symbia E system and to inform you of an update that will be performed by your local Siemens service representative."
Class I - Dangerous
CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.
BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
Philips Medical Systems (Cleveland)
Class I - Dangerous
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
Class I - Dangerous
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.
Class I - Dangerous
Sterility of device may be compromised due to sterile package breakage.
Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123). This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ratio equation used to calculate ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results in IFCC units contains an error. The error results in falsely depressed HbA1cR results.