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Device recall: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
FDA enforcement event 70924 is a device recall by GE Healthcare of Waukesha, WI, initiated 19 Dec 2014 and classified Class II, with 3 product records.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 29 Apr 2015. Initiation: voluntary: firm initiated. GE Healthcare has 44 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Healthcare, Waukesha, WI.
Reason for recall
"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."
Distribution
"US Distribution to the states of: AZ, FL, GA, MO and WI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1405-2015 | GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx | 6 units US | Class II | Terminated | 6 May 2015 |
| Z-1406-2015 | GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx | 6 units in US | Class II | Terminated | 6 May 2015 |
| Z-1407-2015 | GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx | 6 units in US | Class II | Terminated | 6 May 2015 |
Context
Other enforcement events for GE Healthcare
All 44 events for GE Healthcare
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to the states of: AZ, FL, GA, MO and WI."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Apr 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.