Recall Z-0301-2026 ยท KPS System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
| Date | Oct 23, 2025 (initiated Sep 12, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Package design/selection |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 9/12/2025 via letter (USPS first class). The notice explained the issue, potential safety issue, and requested the following: "Actions to be taken by Customer/User: You have previously been formally notified that these Impacted Systems have reached their End of Guaranteed Service life. GE HealthCare does not have the ability to correct these devices. GE HealthCare requests you to immediately STOP USING your Impacted System(s). As these devices are no longer supported and are no longer serviceable, continu |
| Quantity | 1 unit |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.