Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Topcon Medical Laser Systems
Class I - Dangerous
When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however, inadvertently the new part was not implemented. During complaint evaluati
Class I - Dangerous
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aqui
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights.
Etac Supply Center Ab
Class I - Dangerous
Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Swift Mobil shower chair loses a caster and thus becomes instantly unstable, there is potiential risk for harm or injury.