Recall Z-0840-2015— GE OEC Medical Systems, Inc

Name: FDA recall Z-0840-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-15

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2014-09-15, terminated 2015-05-20. It names one FDA 510(k) clearance: K123603. Product: GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.. Reason: mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3)..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-09-15
Terminated: 2015-05-20
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K123603 — OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIMEGe Healthcare Surgery GE Oec Medical Systems, Inc.·cleared 2013-05-17

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 OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

Reason for recall

mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).

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