Siemens E.cam and Symbia Systems Recalled for Detector Time Loss
Siemens Medical Solutions is recalling E.cam and Symbia systems with foresight detectors because they may lose detector time information during gated or dynamic acquisitions.
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 the source text explicitly states that the probability of the defect occurring is remote, fitting the criteria for a moderate severity rating involving low-risk or precautionary issues.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 5,066 E.cam and Symbia systems equipped with foresight detectors. The recall is due to a defect where the systems may lose some detector time information when performing gated or dynamic acquisitions. The affected systems are used for SPECT, CT, and SPECT+CT imaging to detect or image the distribution of radionuclides in the body or organ.
The company's risk analysis indicates that the probability of this occurrence is remote. The systems were distributed nationwide across the United States, including all 50 states, the District of Columbia, and Puerto Rico. Specific model numbers and serial numbers for the affected E.cam and Symbia series are listed in the official recall documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- E.cam or Symbia systems that use foresight detectors - Product Usage: 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.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Category
- Medical Device — Imaging Systems
- Hazard
- Affected units
- 5,066
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)
- Model Numbers: 8717733
- 8717741
- 10275007
- 10275009
- 10275010
- 10607649
- 10764801
- 10764802
- 10764803
- 10764804
- 10275879
- 10413009
- 4380213
- 4380221
- 5242826
- 5977066
- 5977074
- 5984005
- 5989079
- 5989087
Distribution
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