CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report
Elscint SPX6 recalled by Ge Medical Systems Israel
Ge Medical Systems Israel, Functional Imaging is recalling Elscint SPX6. The recall was initiated on 12 Sep 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-0293-2026
- FDA event ID
- 97647
- Recalling firm
- Ge Medical Systems Israel, Functional Imaging, Haifa
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Sep 2025
- FDA classified
- 23 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Imaging Equipment
Timeline
| 12 Sep 2025 | Recall initiated by company | |
| 23 Oct 2025 | Classified by FDA | +41 days |
| 29 Oct 2025 | Published in enforcement report | +6 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 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.
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
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Where it was distributed
Worldwide
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 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.
Which lots are affected?
all serial numbers in distribution
Where was it sold?
Worldwide
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
13 other products · FDA event 97647More recalls from Ge Medical Systems Israel, Functional Imaging
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