The e — Class II medical device recall Z-0687-2016
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2016-01-27, distributed in FL, GA, IN, MD, MO, NY, SD, TN. To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its e
| Recall number | Z-0687-2016 |
|---|---|
| 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 | 2015-12-31 |
| Classified | 2016-01-21 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2016-12-23 |
| Distributed | FL, GA, IN, MD, MO, NY, SD, TN |
| Countries outside the US | AU, IN |
| Quantity | 10 |
| Serial numbers | 70004, 70038, 70039, 70040, 70041, 70042, 70043, 70044, 70045, 70046 |
Product
The e.cam Dual Signature Gamma Camera 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 588keV.
Reason for recall
To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.
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-0687-2016. 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.