Class I - Dangerous
CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Class I - Dangerous
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Class I - Dangerous
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Class I - Dangerous
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
Hardy Diagnostics
Class I - Dangerous
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Class I - Dangerous
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Class I - Dangerous
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
PHILIPS HOME HEALTHCARE SOLUTION
Class I - Dangerous
After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
Class I - Dangerous
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Boston Scientific
Class I - Dangerous
Accelerated battery depletion may result in a need for device replacement earlier than expected.
Class I - Dangerous
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Class I - Dangerous
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Class I - Dangerous
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Class I - Dangerous
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Class I - Dangerous
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
Class I - Dangerous
The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Boston Scientific
Class I - Dangerous
Accelerated battery depletion may result in a need for device replacement earlier than expected.
Class I - Dangerous
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.