Other Medical Devices

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).

The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.