Siemens Symbia Gamma Camera Recall for Collimator Change Instructions
Siemens is recalling 726 Symbia gamma camera systems worldwide to provide supplemental instructions clarifying the proper collimator change procedure.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a documentation/instructional clarification rather than a reported injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 726 units of the Symbia gamma camera system, a diagnostic x-ray system intended to produce cross-sectional images of the body. The recall covers systems distributed worldwide, including the United States and numerous foreign countries.
The recall was initiated following a customer complaint reported via the MedWatch process. An investigation determined that while the existing user manual is correct, additional supplemental instructions with visual aids are needed to further clarify and emphasize the proper collimator change procedure.
Healthcare facilities and users of the affected systems should contact Siemens Medical Solutions USA, Inc. to obtain the supplemental instructions. The recall is classified as Class II by the FDA.
The recalled product
- 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 ax
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 726
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 10275879
- 10413009
- 04380213
- 04380221
- 05242826
- 05977066
- 05977074
- 05984005
- 05989079
- 05989087
- 05989095
- 05991109
- 05991117
- 05992099
- 07324119
- 07324135
- 07324143
- 07324150
- 07760809
- 07760932
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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