PlainRecalls
FDA Devices Moderate Class II Ongoing

Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

Reported: October 29, 2025 Initiated: September 12, 2025 #Z-0302-2026

Product Description

Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

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.

Details

Units Affected
205 units
Distribution
Worldwide
Location
Haifa

Frequently Asked Questions

What product was recalled?
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging. Recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING. Units affected: 205 units.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on October 29, 2025. Severity: Moderate. Recall number: Z-0302-2026.