ddR Formula B X-ray System — Class II medical device recall Z-3248-2018
Ongoing recall by Swissray Medical, reported 2018-10-03, distributed nationwide. Possible injury due to movement of the arm, calibration loss and communication loss.
| Recall number | Z-3248-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Swissray Medical, Hochdorf, Switzerland |
| Recall initiated | 2016-08-09 |
| Classified | 2018-09-25 |
| Reported by FDA | 2018-10-03 |
| Distributed | Nationwide (US) |
| Quantity | 26 units |
Product
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Reason for recall
Possible injury due to movement of the arm, calibration loss and communication loss.
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-3248-2018. 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.