Stationary Fluoroscopic X-ray System CombiDiagnost R90 — Class II medical device recall Z-0612-2019
Terminated recall by Philips Medical Systems Gmbh, DMC, reported 2019-02-20, distributed nationwide. kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dos
| Recall number | Z-0612-2019 |
|---|---|
| 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 | 2018-11-07 |
| Classified | 2019-02-12 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2020-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, CH, CL, CZ, DE, EG, ES, FR, GB, GH, IR, IT, JO, LB, LU, LV, MX, MY, NL, NP, NZ, PH, PT, RS, SA, TR, ZA |
| Quantity | 146 |
| Model numbers | 709030 |
Product
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Reason for recall
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
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-0612-2019. 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.