Class II — Siemens Medical Solutions USA, Inc.
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 10 |
| Distribution | Distributed in the states of Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India. |
| Initiated | 2015-12-31 |
| Classified | 2016-01-21 |
| Terminated | 2016-12-23 |
| Recall number | Z-0687-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc. (Z-0687-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73038/
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