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Open, Classified

Revolution Apex, Revolution CT with Apex Edition

FDA Recall Z-0815-2022 · Posted 2022-04-05

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2021-06-30
Product Quantity273 (51 US, 222 OUS) in total

Reason for Recall

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

Firm Action

GE Healthcare sent an Important Electronic Product Radiation Warning letter dated February 8, 2022 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. GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Healthcare Services at 1 (800) 437-1171 or local Service Representative.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide - US Nationwide distribution.

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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