E — Class II medical device recall Z-1297-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-03-25, distributed nationwide. Radial motor drives replaced during a customer service action were incorrectly assembled backwards.
| Recall number | Z-1297-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, United States |
| Recall initiated | 2012-04-11 |
| Classified | 2015-03-19 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 4,856 systems |
| Serial numbers | 05173/5992099, 08501/7823920, 10000, 10001, 10002, 10003, 10004, 10005, 10006, 10007, 10008, 10009, 1001, 10010, 100100018, 10011, 10012, 10013, 10014, 10015, 10016, 10017, 10018, 10019, 1002 and 475 more |
Product
E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
Reason for recall
Radial motor drives replaced during a customer service action were incorrectly assembled backwards.
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-1297-2015. 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.