Medical Devices Recalls

Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower

In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.

Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability

Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.