CombiDiagnost GCF — Class II medical device recall Z-1328-2020
Ongoing recall by Philips Medical Systems Gmbh, DMC, reported 2020-02-26, distributed nationwide. When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that spec
| Recall number | Z-1328-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems Gmbh, DMC, Hamburg, Germany |
| Recall initiated | 2019-12-19 |
| Classified | 2020-02-20 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2020-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, CA, CH, CL, CN, CO, CY, CZ, DE, DO, EG, ES, FR, GB, GH, HU, IR, IT, JO, KE, KW, LB, LU, LV, MX, MY, NG, NL, NP, NZ, OM, PH, PL, PT, RO, RS, SA, TH, TR, VN, ZA |
| Quantity | 116 |
| Reason classes | device malfunction |
Product
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Reason for recall
When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.
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-1328-2020. 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.