[Recalled] Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — GE HealthCare has become aware that certain Nuclear Medicine systems that are p… | FDA 2025-09-12
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging |
|---|---|
| Brand / manufacturer | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0291-2026 |
| Country of notice | Israel |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 12 September 2025 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in Israel and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.