Official recall record
SMV DSI, System, Tomography, Computed, Emission
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-12-10
- Country of alert
- Israel
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
What the authority reported
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 potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-12-24 · US FDA — Medical Devices
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, - 2025-09-12 · US FDA — Medical Devices
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical Devices
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging