FDA Medical devices recall ·
Elscint Model 4XX recall
- Recall number
- Z-0291-2026
- Date
- (initiated September 12, 2025)
- Company / brand
- Ge Medical Systems Israel, Functional Imaging
9, Andrey Sakharov, Haifa, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 64 units
- Hazard tags
- Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
all serial numbers in distribution
Distribution
Worldwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0291-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.