Philips recalls BV Pulsera mobile X-ray systems with Software Release 2.3-A due to missing maximum surface temperature guidelines for the X-ray tank, which can cause burns. Affected units have specific model numbers and serials listed in the recall.
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 systems with Software Release 2.3-A because the instructions don't specify the maximum surface temperature of the X-ray tank. This can cause burns if the system is used without proper temperature guidelines.
The X-ray tank (which houses the X-ray tube, beam filter, and cooling oil) and image intensifier/detector lack specified maximum surface temperatures in the instructions. This means users might not know when the system could become hot enough to cause burns.
Healthcare facilities and medical professionals who use Philips BV Pulsera mobile X-ray systems with Software Release 2.3-A are most at risk. The recall affects specific model numbers and serials listed in the recall notice.
Check for model number 718095 and serial numbers starting with 2368 257 252 1234 1139 1989 12662 604 1858 4196 2046 1826 312 313 1360 2438 802 844 1620 3007 2348 318 303 2737 2739 1192 1258 2094 168 167 317 1662 217 12681 2443 1936 2573 3102 195 134 135 682 2759 3892 3121 1203 3398 1758 13707 1784 12454 515 2271 250 721 478 57 2747 1425 750 2588 621 934 1066 1605 1658 2186 3187 3237 3239 12923 12924 985 1603 4239 4240 13212 12463 3418 4528 4529 3744 4264 126 3087 892 1307 668 3802 2439 4616 12922 13779 13026 13029 13496 13025 2549 13538 13539 3573 13028 733 12650 1685 1959 3584 3661 3663 4706 12466 13032 13498 3662 13030 13033
Look for model number 718095 and serial numbers listed in the recall notice
The instructions don't specify maximum surface temperatures for the X-ray tank, which can lead to burns if the system gets too hot.
Check for model number 718095 and serial numbers starting with the specific sequence listed in the recall notice.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0356-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-0356-2022 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.
