SMV DSI nuclear medicine systems recalled over a potential detector fall
GE HealthCare is recalling 3 units of the SMV DSI nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.
What this means for you
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: Scored 3 under the risk-of-harm criterion: the firm describes a potential detector fall that could lead to life-threatening bodily injury, and the record states no falls or injuries have been reported.
Plain-English summary
The SMV DSI, an emission computed tomography system, is being recalled by GE Medical Systems Israel, Functional Imaging.
GE HealthCare has become aware that certain nuclear medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. The firm states this could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity, and that if this occurs it can potentially result in a detector fall and lead to life-threatening bodily injury. The record states there have been no reports of detector falls or injuries as a result of this potential issue.
The record lists 3 units, covering all serial numbers in distribution, with no UDI/DI applicable. Distribution covered the US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain, Chile, Germany, Iran and Greece. The FDA has classified the action as Class II.
GE HealthCare states the impacted systems are those that have not been manufactured for several years, and that End of Guaranteed Service for them has previously been communicated. Facilities should follow GE HealthCare's instructions.
The recalled product
- Product
- SMV DSI, System, Tomography, Computed, Emission
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Affected units
- 3
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 (1)
- UDI/DI Not applicable: All serial numbers in distribution
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 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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