Philips North America Llc Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

Recommended Action

Per FDA guidance

Philips issued an Urgent Medical Device Correction letter in the USA on 11/12/21 via Certified mailing United States Postal Service. Recalling outside the US is done through the local Philips organizations in the respective countries Letter states reason for recall, health risk and action to take: Pay attention to the Heat Indication Level Icons shown in the Viewing Station to know the temperature of the X-Ray Tank. o Follow the instructions provided in Annex I of this letter for a safe use of the system. o Circulate this notice to all users of this device so that they are aware of the issue. o Place this Field safety Notice with the documentation of the of your system o Transfer this Field Safety notice within your organization or to any organization, if the affected devices have been transferred. o Complete the enclosed Customer Reply Form and send it back to confirm that users have reviewed and understood this Urgent Field Safety Notice. 5. Actions planned by Philips IGT Systems to correct the problem Philips is informing customers through this Urgent Field Safety Notice and providing the Addendum to the Instructions For Use of the BV Endura Release 2.3, BV Pulsera Release 2.3 and Veradius Unity Release 2.1 systems.