FDA Device recall Z-1263-2016
The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-…
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-… by Siemens Medical Solutions Usa, citing we received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1263-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-26 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Reason
We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbia E systems that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper collimator change
Identifiers
| code_info | 10275879, 10413009, 04380213, 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109,…10275879, 10413009, 04380213, 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823920, 07823938, 07823946, 07823953, 07823961, 07823979, 10151531, 10151532, 10520745 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1263-2016%22
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