FDA-Device2012-11-28Class II
GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare, LLC
Hazard
It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Sold states
Nationwide Distribution
Affected count
364 total units installed in US
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0198-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief