Artis Q — Class II medical device recall Z-0978-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-04-27, distributed nationwide. If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in whi
| Recall number | Z-0978-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2022-02-23 |
| Classified | 2022-04-21 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 33 systems |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04056869010014 |
| Serial numbers | 105016, 105017, 105018, 105025, 105026, 105028, 105029, 105030, 105031, 105032, 105033, 105100, 105105, 105110, 105112, 105114, 105115, 105119, 105120, 105121, 105122, 105123, 105124, 105125, 105128 and 8 more |
| Model numbers | 10848353 |
Product
Artis Q.zen floor, Model Number 10848353
Reason for recall
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
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-0978-2022. 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.