[Recalled] GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 51
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense |
|---|---|
| Brand / manufacturer | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1054-2023 |
| Country of notice | Israel |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 19 December 2022 |
| EAN / barcode | 00840682140829 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
This Class I 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
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
Related recalls from GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
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.