Recall Z-0985-2015— GE Healthcare

Name: FDA recall Z-0985-2015
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: K133705. Product: GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.. Reason: Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported..

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

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

GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

Reason for recall

Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.

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