Philips recalls mobile X-ray systems with software release 2.3 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 mobile X-ray imaging systems with software version 2.3 because the instructions don't state the maximum safe temperature for the X-ray tank. This could lead to burns if the tank overheats. Affected units have specific model and serial numbers listed in the recall notice.
The X-ray tank housing the X-ray tube, beam filter, and cooling oil does not have a specified maximum surface temperature in the instructions. This means the tank could overheat and cause burns to anyone in contact with it during operation.
Healthcare professionals using Philips BV Endura mobile X-ray systems with software release 2.3 are most at risk. Patients and staff near the X-ray tank during operation could experience burns if the tank overheats.
Check for model number 718075 and serial numbers starting with 173. The system was sold with software release 2.3 between 2020 and 2023. The unique device identifier (UDI) is listed in the recall notice.
Identify your model number (718075) and serial number to confirm if your unit is affected.
If you have the affected software version, stop using the system until you can contact Philips for further instructions.
The instructions for use do not specify the maximum surface temperature of the X-ray tank, which can cause burns if the tank overheats.
Software release 2.3 of the BV Endura mobile X-ray system.
Look for model number 718075 and serial numbers starting with 173. The system was sold with software release 2.3 between 2020 and 2023.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0355-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-0355-2022 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.
