The FDA announced on May 8, 2020, that GE Healthcare is recalling OEC 9800 and OEC 9900 Elite fluoroscopic mobile C-Arms. The devices fail to display required radiation dose values as mandated by federal regulations.
How to tell if you have it
- Brand: GE Healthcare
- Product: OEC 9800, OEC 9900 Elite
- Quantity: 221 units
The hazard
Field Service Engineers changed the dose display from AKR/CAK to DAP upon customer request. This configuration does not comply with 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006, to display continuous updates of AKR and CAK values.
Context
GovInfoNow's records show GE Healthcare has 12 other recalls on record since January 25, 2018. Other recent recalls include the GE Healthcare Enterprise Archive V8 Software Recall (July 31, 2026) and the GE Healthcare Centricity Universal Viewer Zero Footprint Client Recall (January 16, 2026). Similar product recalls include the Siemens ARTIS pheno X-ray System Recall (March 9, 2026) and the GE Medical Systems Senographe Pristina Mammography Machines recall (October 24, 2025).