Medical Devices Recalls

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.

Due to the release of nonconforming Intraocular Lenses (IOLs).

The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the band is too small, the treatment may be more aggressive. It is important to note that elastic band force decreases over time. If the band is too small and still applied, the band could break. Both circumstances could result in temporary patient discomfort.

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system

Non-sterile product was shipped to customers labelled as sterile.

There is a risk that the device can start a fire if flammable liquids contact and enter the device.

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.

Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it may lead to delay or interruption of therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur.

The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.

There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.