FDA Device recall Z-0356-2022

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system

FDA Device
Class II
ongoing
Published 2021-12-15

On 2021-12-15 the FDA classified a Class II recall of BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system by Philips North America, citing 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/detect….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0356-2022
Classification	Class II
Status	ongoing
Initiated	2021-11-12
Published	2021-12-15
Last updated	2026-09-13 11:56 UTC
Company	Philips North America
Distribution	US

Product

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

Reason

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

Identifiers

code_info	serial Numbers: 2368 257 252 1234 1139 1989 12662 604 1858 4196 2046 1826 312 313 1360 2438 802 844 1620 3007 2348 318… serial Numbers: 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 1197 2564 983 236 481 1983 386 13027 74 75 589 693 154 2735 13242 377 798 4466 687 77 565 1101 112 2836 2837 1703 13006 13014 2427 12954 1982 4740 13796 13795 561 13823 13824 597 671 1089 113 1732 13156 1866 2423 1427 325 108 3721 3189 326 3093 603 622 924 282 1984 1152 3009 1059 1136 981 2342 2666 196 73 1650 793 794 799 800 444 3857 289 2866 2020 1138 1547 1548 2708 13604 415 548 3186 2409 2760 3485 3487 2012 48 1869 50 927 193 351 383 384 2811 2821 1885 12566 1937 2365 2810 3078 12618 12619 12620 12621 12622 12623 12624 12625 12626 12628 4080 13051 3534 3301 2279 2385 194 609 52 2185 2311 2366 2177 1461 488 489 492 13519 3568 4758 4759 130 398 3760 2978 3594 1609 1709 2284 4475 285 4390 740 485 2430 38 635 1938 117 13810 3513 13 951 13456 12495 1140 2095 639 1990 2300 1448 897 577 1820 378 259 4381 1744 1745 1746 3512 505 2707 2888 2706 40 1575 2644 22

code_info

serial Numbers: 2368 257 252 1234 1139 1989 12662 604 1858 4196 2046 1826 312 313 1360 2438 802 844 1620 3007 2348 318…

serial Numbers: 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 1197 2564 983 236 481 1983 386 13027 74 75 589 693 154 2735 13242 377 798 4466 687 77 565 1101 112 2836 2837 1703 13006 13014 2427 12954 1982 4740 13796 13795 561 13823 13824 597 671 1089 113 1732 13156 1866 2423 1427 325 108 3721 3189 326 3093 603 622 924 282 1984 1152 3009 1059 1136 981 2342 2666 196 73 1650 793 794 799 800 444 3857 289 2866 2020 1138 1547 1548 2708 13604 415 548 3186 2409 2760 3485 3487 2012 48 1869 50 927 193 351 383 384 2811 2821 1885 12566 1937 2365 2810 3078 12618 12619 12620 12621 12622 12623 12624 12625 12626 12628 4080 13051 3534 3301 2279 2385 194 609 52 2185 2311 2366 2177 1461 488 489 492 13519 3568 4758 4759 130 398 3760 2978 3594 1609 1709 2284 4475 285 4390 740 485 2430 38 635 1938 117 13810 3513 13 951 13456 12495 1140 2095 639 1990 2300 1448 897 577 1820 378 259 4381 1744 1745 1746 3512 505 2707 2888 2706 40 1575 2644 22

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0356-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.