DeGotzen XRay unit XGenus Dental X-ray unit — Class II medical device recall Z-1020-2013
Terminated recall by DeGotzen, reported 2013-04-24, distributed nationwide. It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
| Recall number | Z-1020-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeGotzen, Olgiate Olona Varese, N/A, Italy |
| Recall initiated | 2012-09-26 |
| Classified | 2013-04-17 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2018-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 159 units |
| Reason classes | labeling |
Product
DeGotzen XRay unit XGenus Dental X-ray unit.
Reason for recall
It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
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-1020-2013. 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.