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Terminated

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

FDA Recall Z-0985-2015 · Posted 2015-01-15

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeJAK
Date Initiated2014-12-19
Date Terminated2015-04-29
Product Quantity13 (7 US, 6 OUS)

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.

Firm Action

Consignees were sent on 12/19/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC # 25457 dated December 19, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US phone 800-437-1171, Japan 0120-055-919, other countries contact your local GE Healthcare Service Representative).

Root Cause

Process control

Distribution Pattern

US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.

Official Source

View FDA Recall →

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

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