FDA Device recall Z-1044-2026
SMV DSX New Line, System, Tomography, Computed, Emission
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of SMV DSX New Line, System, Tomography, Computed, Emission by Ge Medical Systems Israel Functional Imaging, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1044-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-10 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Ge Medical Systems Israel Functional Imaging |
| Distribution | n/a |
Product
SMV DSX New Line, System, Tomography, Computed, Emission
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 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.
Identifiers
| code_info | UDI/DI Not applicable: All serial numbers in distribution |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1044-2026%22
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