openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
BrivoXR285amx - PN 5555000, 5555000-2
Distribution pattern
US Distribution to the states of: AZ, FL, GA, MO and WI.
device · product 2 of 3
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
OptimaXR200amx PN 5555000-3, PN5555000-4
Distribution pattern
US Distribution to the states of: AZ, FL, GA, MO and WI.
device · product 3 of 3
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
OptimaXR220amx PN 5555000-5, PN5555000-6
Distribution pattern
US Distribution to the states of: AZ, FL, GA, MO and WI.
