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Open, Classified

Revolution EVO, Optima CT660, Optima CT680 CT Systems.

FDA Recall Z-1900-2021 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2021-06-14
Product Quantity3665

Reason for Recall

Improperly loaded software options may result in additional X -ray radiation exposure to the patient.

Firm Action

GE Healthcare will send an Important Electronic Product Radiation Warning letter to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take to prevent this issue.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

3,665 (US = 956; OUS = 2,709)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131576OPTIMA CT660Ge Medical Systems, LLC · 2013-08-30

Official Source

View FDA Recall →

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

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