Interventional Fluoroscopic X-Ray System — Class II medical device recall Z-1288-2021
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2021-03-31, distributed nationwide. Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown o
| Recall number | Z-1288-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2021-02-26 |
| Classified | 2021-03-22 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2021-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 29 systems |
Product
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason for recall
Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
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-1288-2021. 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.