ddR Formula B X-ray System — Class II medical device recall Z-3191-2018
Ongoing recall by Swissray Medical, reported 2018-09-26, distributed nationwide. Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly
| Recall number | Z-3191-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Swissray Medical, Hochdorf, N/A, Switzerland |
| Recall initiated | 2016-11-18 |
| Classified | 2018-09-18 |
| Reported by FDA | 2018-09-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CN, DE, MY, RU, ZA |
| Quantity | 27 devices |
Product
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Reason for recall
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
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-3191-2018. 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.