Siemens Symbia E Camera System Recalled for Loose Rear Casters
Siemens Medical Solutions USA is recalling 531 Symbia E camera systems because the collimator cart rear casters may become loose.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 the hazard involves a mechanical component (loose casters) that poses a risk of harm but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 531 Symbia E camera systems, which are Emission Computed Tomography Systems used for nuclear medicine diagnostic imaging. The recall was initiated after the company received reports indicating that the rear casters on the collimator cart may become loose.
The affected units are distributed worldwide, including nationwide in the United States and in numerous foreign countries. The recall covers both Symbia E Dual Head Systems (Model Number 10275879) and Symbia E Single Head Systems (Model Number 10413009) with specific serial numbers listed in the official recall documentation.
Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the potential caster issue.
The recalled product
- Product
- Symbia E camera system. Emission Computed Tomography 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 588 keV. Nuclear…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 531
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)
- 1) Symbia E Dual Head System
- Model Number: 10275879
- Serial Numbers: 1066
- 1090
- 1184
- 1185
- 1552
- 1443
- 1442
- 1479
- 1500
- 1505
- 1519
- 1534
- 1535
- 1539
- 1546
- 1554
- 1559
- 1562
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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