Recall Z-1045-2026 ยท KPS System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
SMV DSI, System, Tomography, Computed, Emission
| Date | Jan 9, 2026 (initiated Dec 10, 2025) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Package design/selection |
| Action | GE Healthcare began notifying their consignees by telephone on 12/10/2025, followed by an URGENT MEDICAL DEVICE CORRECTION UPDATE notice distributed on 01/05/2025 via US mail. The notice explained the issue, safety risk, and requested the consignee stop use of the product. Care should be exercised when deinstalling these systems. To discuss replacement options, your GE HealthCare account representative. Should be contacted. |
| Quantity | 3 units |
| Distribution | US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002553 | DS DS I-SERIES Smv America, Sep 15, 2000 |