Elscint SPX6 recall
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Why was Elscint SPX6 recalled?
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. 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.
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?
all serial numbers in distribution
- Product
- Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Quantity
- 28 units
- Distribution
- Worldwide
- Recall date
- October 29, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)