FDA Device recall Z-1262-2016
The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmace…
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmace… 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-1262-2016 |
| 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 E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body
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-1262-2016%22
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