The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop

FDA device recall Z-0955-2015 · posted 2015-01-26 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

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

Action taken

GE Healthcare Planned Action (s) to repair defect or to bring product into Compliance letter dated January 16, 2015 to GE Healthcare. 1. A GE Healthcare service representative will perform a noise specification and tolerance calibration to correct all affected systems via Field Action Instruction (FMI 25457). 2. A customer notification letter which includes a statement that GE Healthcare will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. GE Healthcare Surgery will implement this CAP by May 1, 2015. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). Call Center phone numbers: United States: 800 437-1171, Japan: 0120-055-919 Information For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

JAK

Quantity affected

13 units

Distribution

US Distribution to the states of CA, FL, IL, NY, UT and WA.

Date initiated

2014-11-12

Date posted

2015-01-26

Date terminated

2015-04-29

Location

Waukesha, WI

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