BV Pulsera with Software Release 2 — Class II medical device recall Z-0356-2022
Ongoing recall by Philips North America Llc, reported 2021-12-15, distributed nationwide. Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-
| Recall number | Z-0356-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-11-12 |
| Classified | 2021-12-09 |
| Reported by FDA | 2021-12-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, GY, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 1,201 units |
| UPC / GTIN / UDI-DI | 00884838055506 |
| Serial numbers | 100, 1016, 1017, 1018, 102, 1026, 1027, 1028, 1029, 103, 1030, 1032, 1033, 1037, 1038, 104, 1041, 1048, 1049, 1055, 1058, 1059, 1065, 1066, 1067 and 475 more |
| Model numbers | 718095 |
Product
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
Reason for 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0356-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.