Medical equipment, implants, and diagnostic devices
Smith & Nephew, Inc., Endoscopy Div.
Sterility of device is compromised due to breach in the packaging
May contain small amounts of ethylene glycol residue
May contain small amounts of ethylene glycol residue
Natus Medical Incorporated
The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).
Biomet Microfixation
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
May contain small amounts of ethylene glycol residue
ConforMIS
May contain small amounts of ethylene glycol residue
During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control switches and/or the control board assembly.
Synthes (USA) Products
potential for mechanical failures such as breakage.
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.
Toshiba American Medical Systems
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Toshiba American Medical Systems
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Toshiba American Medical Systems
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals.
Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.
Clinical Innovations
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
Toshiba American Medical Systems
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S