Philips DigitalDiagnost software 4 — Class II medical device recall Z-0239-2019
Terminated recall by Philips Medical Systems Gmbh, DMC, reported 2018-10-31, distributed nationwide. Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first imag
| Recall number | Z-0239-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems Gmbh, DMC, Hamburg, N/A, Germany |
| Recall initiated | 2018-09-19 |
| Classified | 2018-10-24 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2023-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, HK, HU, ID, IL, IN, IR, IT, JO, JP, KR, KW, LU, LV, MX, NL, NO, NZ, PA, PE, PL, PT, QA, RO, SA, SE, SG, SI, TH, TR, TW, ZA |
| Quantity | 829 units |
| Reason classes | software |
| Serial numbers | 541056/SN14000004, 545900/SN14000093, 546645/SN14000046, 547772/SN14000040, 548858/SN14000056, 548953/SN15000031, 549825/SN14000110, 549865/SN14000071, 550502/SN14000100, 550562/SN14000109, 551694/SN14000104, 551776/SN14000106, 553110/SN15000111, 554080/SN15000110, 563654/SN15000364, 571802/SN16000253, 585582/SN17000276, SN14000001, SN14000002, SN14000003, SN14000014, SN14000018, SN14000024, SN14000026, SN14000031 and 475 more |
| Model numbers | 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228 |
Product
Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
Reason for recall
Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline
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-0239-2019. 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.