Class I - Dangerous
Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Toshiba Kalare DREX-KL80 X-ray generator
Toshiba American Medical Systems
Class I - Dangerous
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
Terumo Cardiovascular Systems
Class I - Dangerous
Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.
Artis Q and Q.Zen fluoroscopic x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
Class I - Dangerous
Handle may break during use.
Artis Zee and Zeego fluoroscopic x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
The ABL800 Model#:All
Radiometer America
Class I - Dangerous
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Class I - Dangerous
CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.
Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
Terumo Cardiovascular Systems
Class I - Dangerous
Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.
Toshiba Ultimax DREX-ULT80 X-ray generator
Toshiba American Medical Systems
Class I - Dangerous
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
Axiom Artis fluoroscopic x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
Class I - Dangerous
Handle may break during use.
Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Villa Sistemi Medicali S.P.A.
Class I - Dangerous
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Villa Sistemi Medicali S.P.A.
Class I - Dangerous
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
Turon Impaction Fixture
Encore Medical
Class I - Dangerous
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Class I - Dangerous
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
The See Clear Company
Class I - Dangerous
Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Villa Sistemi Medicali S.P.A.
Class I - Dangerous
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
MicroAire K-Wires
MicroAire Surgical Instruments
Class I - Dangerous
Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).