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Completed

Revolution CT

FDA Recall Z-2004-2021 · Posted 2021-07-08

Recalling FirmGE Healthcare, LLC
Recall StatusCompleted
Product CodeJAK
Date Initiated2021-03-19
Product Quantity197 (US = 40; OUS = 157)

Reason for Recall

GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

Firm Action

GE Healthcare will perform an initial site assessment and replace the collimator, if needed. This will be followed by bi-weekly remote monitoring of the system s log file. Finally, GE Healthcare will install a currently under development software patch, added to the daily fast calibration to automatically and reliably detect this failure should it occur. All of these actions will be performed at no cost to the customer. For questions call 262-544-3217.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide distribution - US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionGe Medical Systems, LLC · 2019-07-26K163213Revolution 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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