Artis Q biplane — Class II medical device recall Z-2303-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-07-04, distributed nationwide. After the Large Display returns from power save mode, it may not show an image, and stay black without showing
| Recall number | Z-2303-2018 |
|---|---|
| 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 | 2018-05-01 |
| Classified | 2018-06-27 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2019-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, DK, EE, ES, FI, FR, GB, HK, HR, ID, IE, IL, IN, IT, JP, KR, LK, LU, MX, NL, NO, NZ, PH, PL, PT, PY, RU, SA, SE, SG, TH, TR, TW, ZA |
| Quantity | 5 |
Product
Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.
Reason for recall
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
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-2303-2018. 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.