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Terminated

GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications

FDA Recall Z-1589-2016 · Posted 2016-04-29

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-04-20
Date Terminated2016-09-21
Product Quantity26 (US = 4;OUS = 22)

Reason for Recall

An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.

Firm Action

GE Healthcare Systems sent an Urgent Medical Device Correction letter dated April 20, 2016, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - US including FL, GA, NC, and TX and Internationally to AUSTRALIA, CANADA, CHINA, FRANCE, GERMANY, ITALY, JAPAN, REPUBLIC OF KOREA, NORWAY, PERU, SWEDEN UNITED ARAB EMIRATES, UNITED KINGDOM.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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