Safety Alerts

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Philips Medical Systems DMC GmbH CombiDiagnost R90 [Model Number: 709030, 709031] and ProxiDiagnost N90 [Model Number: 706100, 706110] [HKMD No.: 210062].

According to the MHRA, the manufacturer is informing users of the following issues:

• Issue 1: Component damage due to short circuit (CombiDiagnost R90 and ProxiDiagnost N90)
  • If the CombiDiagnost R90 or ProxiDiagnost N90 system experiences an overvoltage / power surge it can cause a short circuit condition within the Main-cabinet (M-Cabinet). The M-Cabinet is physically separated, but in or near the vicinity of the imaging suite. Philips has identified that the overvoltage impacts the Electromagnetic Interference (EMI) filter board which affects the System Power Distribution Unit (SPDU) contained within the M-Cabinet. If this issue occurs, the user may experience one or more of the following:
    • Electrical fire within the M-cabinet
    • See or smell smoke emitting from the M-cabinet
    • Hear a popping sound coming from the M-cabinet
• Issue 2: Table stop due to a broken tabletop cable (ProxiDiagnost N90 only)
  • On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable (see Figure 1). If the tabletop cable is damaged or breaks, the user may not be able to initiate table tilting movements. However, if the cable breaks, the braking mechanism is released, but the system is counterbalanced in all directions which prevents movement of the table. The table can still be brought back to 0° position using the Tilting Switch and the patient can be safely moved off the table.

For further information, please visit https://mhra-gov.filecamp.com/s/d/WSj1HlvhBZM2szyt

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 19 Sep 2023