Recall Z-0769-2016— GE Medical Systems, LLC

Name: FDA recall Z-0769-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-23

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2015-12-23, terminated 2016-09-07. It names one FDA 510(k) clearance: K103476. Product: GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.. Reason: Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-12-23
Terminated: 2016-09-07
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, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.

Reason for recall

Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.

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