Recall Z-1405-2015— GE Healthcare

Name: FDA recall Z-1405-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2014-12-19, terminated 2015-04-29. It names one FDA 510(k) clearance: K103476. Product: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx. Reason: 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..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Terminated: 2015-04-29
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K103476 — BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMXGe Medical Systems, LLC·cleared 2011-06-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.