CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report
SMV DSI, System, Tomography, Computed, Emission recalled
Ge Medical Systems Israel, Functional Imaging is recalling SMV DSI, System, Tomography, Computed, Emission. The recall was initiated on 10 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1045-2026
- FDA event ID
- 98133
- Recalling firm
- Ge Medical Systems Israel, Functional Imaging, Tirat Carmel
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Dec 2025
- FDA classified
- 9 Jan 2026
- Reported
- 21 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 10 Dec 2025 | Recall initiated by company | |
| 9 Jan 2026 | Classified by FDA | +30 days |
| 21 Jan 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
SMV DSI, System, Tomography, Computed, Emission
Where it was distributed
US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
Stores named: Walmart
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI Not applicable: All serial numbers in distribution
Where was it sold?
US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 98133More recalls from Ge Medical Systems Israel, Functional Imaging
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