All Recalls

There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.

Potential risk for helium gas inside the MR examination room during a magnet quench

Potential risk for helium gas inside the MR examination room during a magnet quench

Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

This device was mislabeled and is not the correct component for this patient.

Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

The integrity of the sterile packaging is potentially compromised.

The integrity of the sterile packaging is potentially compromised.

Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.

Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.

The invasive pressure visual and audible alarms may not activate.

Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.e. false positives)

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Potential risk for helium gas inside the MR examination room during a magnet quench

Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.