The following Pro — Class II medical device recall Z-2256-2023
Ongoing recall by Siemens Medical Solutions USA, Inc., reported 2023-08-09, distributed in ID, KS, MA, NH, OH, TX, VA. During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ah
| Recall number | Z-2256-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, United States |
| Recall initiated | 2023-07-12 |
| Classified | 2023-07-28 |
| Reported by FDA | 2023-08-09 |
| Distributed | ID, KS, MA, NH, OH, TX, VA |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CO, DE, DK, FI, FR, GB, HK, IL, IT, JP, NL, PT, SG, TR |
| Quantity | 108 systems |
| UPC / GTIN / UDI-DI | 04056869264745, 04056869264752, 04056869264769 |
| Serial numbers | 100101, 100102, 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100208, 100209, 100210, 100211, 100212, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100220, 100221, 100222, 100223 and 41 more |
| Model numbers | 11364751, 11364752, 11364753 |
Product
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
Reason for recall
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.
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-2256-2023. 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.