OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic — Class II medical device recall Z-2300-2018
Terminated recall by Philips Medical Systems Nederlands, reported 2018-07-04, distributed nationwide. The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table wi
| Recall number | Z-2300-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems Nederlands, Best, Netherlands |
| Recall initiated | 2018-05-01 |
| Classified | 2018-06-27 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2020-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 508 |
| Reason classes | device malfunction |
Product
OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
Reason for recall
The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.
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-2300-2018. 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.