cone-beam CT system — Class II medical device recall Z-1101-2019
Ongoing recall by KaVo Dental Technologies LLC, reported 2019-05-01, distributed in NC. ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
| Recall number | Z-1101-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | KaVo Dental Technologies LLC, Charlotte, NC, United States |
| Recall initiated | 2018-12-31 |
| Classified | 2019-04-22 |
| Reported by FDA | 2019-05-01 |
| Distributed | NC |
| Quantity | 230 |
| Reason classes | software |
Product
cone-beam CT system
Reason for recall
ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
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-1101-2019. 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.