The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Presence of leaks near top of the PrismaSate bags
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Class I - Dangerous
LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated.
Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.
Class I - Dangerous
The pouch label was missing the use by date (UBD) of 2018-04.
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Possible presence of foreign material (rust).
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Class I - Dangerous
The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
Philips Medical Systems (Cleveland)
Class I - Dangerous
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.
Class I - Dangerous
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Class I - Dangerous
The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression. This discrepancy may lead to the possibility of an oversized crown fabrication.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.