Class I - Dangerous
Backrest platform stress fracture - the table is not operational in an inclined position
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
A potential for a light system to fall in the operating room.
A potential for a light system to fall in the operating room.
Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
Getinge Usa Sales
Class I - Dangerous
A potential for a light system to fall in the operating room.
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Maquet Cardiovascular
Class I - Dangerous
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
Calibration Serum Level 3 CAL2351
Randox Laboratories
Class I - Dangerous
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
Getinge Usa Sales
Class I - Dangerous
A potential for a light system to fall in the operating room.
A potential for a light system to fall in the operating room.
A potential for a light system to fall in the operating room.
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Getinge Usa Sales
Class I - Dangerous
A potential for a light system to fall in the operating room.
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
Smiths Medical Asd
Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
A potential for a light system to fall in the operating room.
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Philips North America
Class I - Dangerous
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Maquet Cardiovascular
Class I - Dangerous
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
A potential for a light system to fall in the operating room.
Class I - Dangerous
Backrest platform stress fracture - the table is not operational in an inclined position
Class I - Dangerous
Backrest platform stress fracture - the table is not operational in an inclined position
6IN PRESSURE TUBING, List Number MX20617
Smiths Medical Asd
Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Maquet Cardiovascular
Class I - Dangerous
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.
Class I - Dangerous
A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.