Class I - Dangerous
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
Class I - Dangerous
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
Class I - Dangerous
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
Class I - Dangerous
Product had torn/loose seal around the mouthpiece.
Class I - Dangerous
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
Ortho-Clinical Diagnostics
Class I - Dangerous
Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.
Class I - Dangerous
Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
Class I - Dangerous
Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
GE Healthcare
Class I - Dangerous
The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
Class I - Dangerous
The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.
Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Olympus Corporation of the Americas
Class I - Dangerous
New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
Skytron, Div. The KMW Group
Class I - Dangerous
Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Accriva Diagnostics Inc.
Class I - Dangerous
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Stryker Sustainability Solutions
Class I - Dangerous
Mislabeled for size
Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Roche Molecular Systems
Class I - Dangerous
An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).