OnSight 3D Extremity System- X-Ray — Class II medical device recall Z-1207-2019
Terminated recall by Carestream Health, Inc., reported 2019-05-01, distributed nationwide. When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the
| Recall number | Z-1207-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2019-03-19 |
| Classified | 2019-04-23 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2020-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, GB, IR, IT, KR, PH, PT, SA, SG, TH |
| Quantity | 37 units |
| Serial numbers | 10002, 10003, 10004, 10007, 10009, 10010, 10012, 10014, 10018, 10023, 20003, 20004, 20005, 20006, 20007, 20008, 20010, 20012, 20013, 20016, 20017, 20019, 20022, 58000015, 58000020 and 12 more |
| Model numbers | 1743566 |
Product
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
Reason for recall
When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
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-1207-2019. 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.