Philips recalls Veradius Unity mobile X-ray imaging systems with Software Release 2.1-1 due to instructions not specifying maximum surface temperature of X-ray tank, which can cause burns.
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
Philips is recalling Veradius Unity mobile X-ray imaging systems with Software Release 2.1-1 because the instructions don't specify the maximum surface temperature of the X-ray tank. This can lead to burns if the system is used without proper temperature awareness.
The recall is for systems where the instructions do not specify the maximum surface temperature of the X-ray tank (which houses the X-ray tube, beam filter, and cooling oil) and the image intensifier/detector. This can cause burns if the system is used without proper temperature awareness.
Users of Philips Veradius Unity mobile X-ray imaging systems with Software Release 2.1-1 are at risk of burns. Healthcare professionals and facilities using these systems are most affected.
Check for Veradius Unity mobile X-ray imaging systems with Software Release 2.1-1. Model number 718132 and serial numbers listed in the UDI (Unique Device Identification) field.
Ensure the X-ray tank surface temperature is monitored to prevent burns during use.
The model number is 718132.
Software Release 2.1-1.
Check for the model number 718132 and serial numbers listed in the UDI (Unique Device Identification) field.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0357-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-0357-2022 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
