Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brands
- GE HealthCare, Sopha Medical Vision
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GE HealthCare, Sopha Medical Vision
- Product type
- Dual-head Nuclear Medicine Gamma Camera
- Model numbers
- DSXi, DST-XLi, DST-XL, DSTi
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 12, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING or your healthcare provider for instructions. Notification method: Letter
About This Product
Dual-head nuclear medicine gamma cameras from SMV are used for cardiac imaging in medical facilities. They help image cardiac blood flow and function.
Why This Is Dangerous
If the detector mounting is compromised due to inadequate support during transport or relocation after service ends, the detector could detach or fall, risking serious injury.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals must avoid using affected cameras until cleared. The recall could affect patient safety and imaging workflow, with potential procurement delays.
Practical Guidance
How to identify if yours is affected
- Identify DSXi, DST-XLi, DST-XL, and DSTi models in distribution.
- Confirm distribution status as worldwide.
- Check for manufacturer recall communications to determine eligibility for service or replacement.
Where to find product info
Refer to the FDA recall page linked in the notice and GE HealthCare communications for model numbers and serial ranges.
What timeline to expect
Recalls typically require vendor-provided service or replacement steps; exact timelines are not stated in the release.
If the manufacturer is unresponsive
- Escalate to hospital’s risk management or procurement office.
- Contact FDA if the manufacturer does not respond within a reasonable timeframe.
How to prevent similar issues
- Ensure clear procedures for transporting sensitive imaging equipment.
- Verify detector mounting integrity before relocation.
- Monitor End of Guaranteed Service timelines with service providers.
Documentation advice
Maintain copies of recall notices, service correspondence, and any replacement agreements.
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Product Details
Models: DSXi, DST-XLi, DST-XL, DSTi. Distribution: Worldwide. Quantity: 205 units. Sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Past End of Guaranteed Service
- Detector mounting risk could lead to detector fall
- Active recall as of 2025-10-29
- Notification by letter
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Safety Guide
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