MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional… — Class II medical device recall Z-1608-2018
Terminated recall by Philips Medical Systems Nederlands, reported 2018-05-09, distributed nationwide. The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will s
| Recall number | Z-1608-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems Nederlands, Best, N/A, Netherlands |
| Recall initiated | 2018-03-26 |
| Classified | 2018-05-03 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2020-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CN, CO, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, HK, ID, IE, IL, IT, JO, KR, LB, LU, LV, MX, MY, NL, NO, NZ, OM, PH, QA, RS, SA, SE, SG, SI, SK, TH, TR, TW, ZA |
| Quantity | 184 |
| Reason classes | device malfunction |
| Serial numbers | 100, 101, 102, 103, 104, 105, 106, 107, 108, 110, 111, 112, 113, 114, 115, 116, 117, 118, 120, 121, 123, 124, 125, 126, 128 and 88 more |
Product
MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Reason for recall
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
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-1608-2018. 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.