Class I - Dangerous
The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
Class I - Dangerous
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
Class I - Dangerous
The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.
Class I - Dangerous
An error in the assignment of the control range pH in Blood Gas Control
Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
Class I - Dangerous
Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilution. In order to mitigate any risk associated with these rare isolates, the firm has implemented an Expert Rule that suppresses the meropenem result for isolates that display a profile consistent with those that generated a false-susceptible result. The firm has responded to this risk by implementing a set of suppression rules, in a software update, to prevent incorrect results.
Class I - Dangerous
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Olympus Corporation of the Americas
Class I - Dangerous
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Olympus Corporation of the Americas
Class I - Dangerous
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Class I - Dangerous
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Olympus Corporation of the Americas
Class I - Dangerous
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Olympus Corporation of the Americas
Class I - Dangerous
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Class I - Dangerous
Potential esophageal laceration during a patient procedure
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
Class I - Dangerous
The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.
Class I - Dangerous
The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.
Class I - Dangerous
False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay.
Class I - Dangerous
The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.