GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: Medical Device Recall in 2025 - (Recall #: Z-0302-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 12, 2025

Date Posted: October 29, 2025

Recall Number: Z-0302-2026

Event ID: 97647

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.

Status: Ongoing

Product Quantity: 205 units

Code Information:

all serial numbers in distribution

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated