Data Foundry

Medical device recalls 2021

Computed Tomography Systems Revolution CT — Class II medical device recall Z-0242-2022

Ongoing recall by GE Healthcare, LLC, reported 2021-12-01, distributed nationwide. The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam

Recall numberZ-0242-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedFDA mandated
Recalling firmGE Healthcare, LLC, Waukesha, WI, United States
Recall initiated2021-06-30
Classified2021-11-24
Reported by FDA2021-12-01
DistributedNationwide (US)
Quantity105 in

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0242-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.