FDA recall Z-0813-2025

GE Medical Systems, LLC · Class II · device

Product

GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.

Reason for recall

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

Distribution

Worldwide

Key facts

Status: Ongoing
Initiation date: 2024-11-25
Report date: 2025-01-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0813-2025