Medical Devices Recalls

A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.

The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.

Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.

There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.

The keypad buttons on HomeChoice devices may be activated without the operator pressing them.

Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.

N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.

Presence of one inoperable (dead) sensor pad.

Unqualified power assemblies shipped to customers.

In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.

the Instructions for Use (IFU) were inadvertently removed from the kit.

The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.

One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.

Customer notification that the device may be difficult to open or close.

Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used on patients under gas anesthesia.

Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.

Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.

The wheel castor assemblies may be loosening on the stretchers.

The firm is finding that the stretcher chair controllers are moving the chairs involuntarily.

cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.