Class I - Dangerous
The firm is distributing the Rejuvenator device without an approved 510(k).
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
Product was distributed past its expiration date.
Artis zee and Artis zeego systems. x-ray, angiographic system
Siemens Medical Solutions USA
Class I - Dangerous
There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily.
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
Siemens Medical Solutions USA
Class I - Dangerous
Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated.
Disposable Patient Circuit that allows water to leak into the center gas lumen
eye-pak 7407 Tray Support Cover REF 8065740745
Alcon Research
Class I - Dangerous
The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
Pdg Product Design Group
Class I - Dangerous
The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use.
Class I - Dangerous
DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra Systems are intended for anterior screw fixation to the cervical spine (C2-C7). It was discovered in certain lots, that the clips are potentially missing from the TI Vectra Plates resulting in the i
Disposable Patient Circuit that allows water to leak into the center gas lumen
Disposable Patient Circuit that allows water to leak into the center gas lumen
Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
Instratek, Incorporated
Class I - Dangerous
Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
Disposable Patient Circuit that allows water to leak into the center gas lumen
Class I - Dangerous
Disposable Patient Circuit that allows water to leak into the center gas lumen
Disposable Patient Circuit that allows water to leak into the center gas lumen
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Fresenius Medical Care Holdings
Class I - Dangerous
Product was held at temperature above the labeled recommended storage temperature
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
Motion Concepts
Class I - Dangerous
Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner).
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
Amerx Health Care
Class I - Dangerous
Not approved labeling claims (antimicrobial and autolytic debridement)
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
Philips Medical Systems (Cleveland)
Class I - Dangerous
Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode.
Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.