Open, Classified

Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

FDA Recall Z-0242-2022 · Posted 2021-11-24

Recall StatusOpen, Classified

Product CodeJAK

Date Initiated2021-06-30

Product Quantity105 in total

Reason for Recall

The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.

Firm Action

GE sent an Important Electronic Product Radiation Warning Notification letter dated October 4, 2021 to customers, The letter identified the affected product, problem and actions to be taken. Customers were informed that 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 Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide and 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 · 2019-07-26 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.