Siemens e.cam Gamma Camera Recall for Radial Brake Failure
Siemens Medical Solutions is recalling e.cam Gamma Camera systems due to a potential radial brake failure that could allow the detector to drift.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical defect in a medical device that could lead to injury, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 32,296 e.cam Gamma Camera systems. These emission computed tomography systems are intended to detect or image the distribution of radionuclides in the body or organ using planar imaging, whole body imaging, and tomographic imaging.
The recall is due to a potential failure mode related to the radial brake, where the detector was able to drift. This issue led to a redesign of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.
The recall applies only to e.cam systems that were installed before December 31, 2004. Affected model numbers and serial numbers are listed in the official recall documentation. The products were distributed worldwide, including in the United States and numerous other countries.
The recalled product
- Product
- e.cam Gamma Camera, an emission computed tomography system. It is intended 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.
- Affected units
- 32,296
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)
- E.cam Model numbers affected : 4380213
- 4380221
- 5242826
- 5077066
- 5077074
- 5984005
- 5989079
- 5989087
- 5989095
- 5991109
- 5991117
- 5992099
- 7324119
- 7324135
- 7324143
- 7324150
- 7760809
- 7760932
- 7760161
- 7761161
Distribution
Distributed nationwide across the United States.
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