Siemens e.cam Gamma Camera Recall for Missing Operator Manuals
Siemens is recalling 10 refurbished e.cam Dual Signature Gamma Camera systems because complete operator instruction manuals were not sent to customers.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall addresses a documentation issue where instruction manuals were not sent in their entirety, which falls under the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 10 units of the e.cam Dual Signature Gamma Camera system. These devices are used to detect or image the distribution of radionuclides in the body or organ using planar, whole body, and tomographic imaging techniques.
The recall was initiated because the operator instruction manuals for these systems were not sent in their entirety when the units were refurbished and shipped to customers. The affected systems were refurbished between April 6, 2015, and October 6, 2015. Specific material and serial numbers are listed in the agency's structured data.
The affected units were distributed in Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, as well as in Australia and India. Siemens is providing the missing operator instruction manuals to ensure customers have complete documentation for the equipment.
The recalled product
- Product
- The e.cam Dual Signature Gamma Camera 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 588keV.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 10
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 (10)
- serial number 70004
- Material number 10151532 serial numbers 70038
- 70040
- 70041
- 70042
- 70043
- 70044
- 70039
- 70045
- and 70046.
Distribution
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