Recall Z-0955-2015— GE Healthcare

Name: FDA recall Z-0955-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-12

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2014-11-12, terminated 2015-04-29. It names one FDA 510(k) clearance: K133705. Product: The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.. Reason: A required quality control test was not performed during installation associated with the software of the Revolution CT scanner..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2014-11-12
Terminated: 2015-04-29
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K133705 — REVOLUTION CTGe Medical Systems, LLC·cleared 2014-04-11

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

The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

Reason for recall

A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.

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