Mobile Mini C-arm system Part # 1000-0004 — Class II medical device recall Z-0259-2018
Terminated recall by Orthoscan, Inc., reported 2018-01-17, distributed nationwide. OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Sp
| Recall number | Z-0259-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Orthoscan, Inc., Scottsdale, AZ, United States |
| Recall initiated | 2017-08-31 |
| Classified | 2018-01-09 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2021-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, DE, DO, EE, ES, FI, FR, GB, HK, IL, IT, JP, KR, MY, NO, NZ, PL, RU, SA, SE, TW |
| Quantity | 2,012 total |
| Reason classes | software |
| Model numbers | 1000-0004 |
Product
Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
Reason for recall
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
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-0259-2018. 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.