FDA recall Z-0293-2026

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Class II · device

Product

Elscint SPX6; 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.

Distribution

Worldwide

Key facts

Status: Ongoing
Initiation date: 2025-09-12
Report date: 2025-10-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Haifa, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0293-2026