SMV DSX New Line recall
SMV DSX New Line, System, Tomography, Computed, Emission
Why was SMV DSX New Line recalled?
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI Not applicable: All serial numbers in distribution
- Product
- SMV DSX New Line, System, Tomography, Computed, Emission
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Quantity
- 7 units
- Distribution
- US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
- Recall date
- January 21, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)