Recall Z-1989-2014— GE Healthcare, LLC

Name: FDA recall Z-1989-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-04

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-06-04, terminated 2015-05-06. It names one FDA 510(k) clearance: K012389. Product: GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.. Reason: GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-06-04
Terminated: 2015-05-06
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K012389 — REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEMGe Medical Systems, Inc.·cleared 2001-08-10

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, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

Reason for recall

GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.

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