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Open, Classified

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

FDA Recall Z-1951-2019 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2019-01-19
Product Quantity857 (US = 195: OUS = 662)

Reason for Recall

Additional low dose radiation exposure.

Firm Action

GE Healthcare will send a customer letter that provide safety instructions for immediate mitigation of the issue. The customer can continue to use the system with the recommended workaround instruction provided in the customer letter: All affected systems will be corrected with updated software and a User Manual Addendum which re-emphasizes existing pat ient center ing instructions. If you have any questions or concerns regarding this notification. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Device Design

Distribution Pattern

Worldwide - US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163213Revolution CTGe Medical Systems, LLC · 2016-12-16

Official Source

View FDA Recall →

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

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