GE Healthcare GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
Brand
GE Healthcare
Lot Codes / Batch Numbers
BrivoXR285amx - PN 5555000, 5555000-2
Products Sold
BrivoXR285amx - PN 5555000, 5555000-2
GE Healthcare is recalling GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx due to An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure tim. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, FL, GA, MO, WI
Page updated: Jan 10, 2026