RecallRadar

FDA Device recall Z-1951-2019

Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applicati…

On 2019-07-24 the FDA classified a Class II recall of Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applicati… by Ge Healthcare, citing additional low dose radiation exposure.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1951-2019
ClassificationClass II
Statusongoing
Initiated2019-01-19
Published2019-07-24
Last updated2026-09-13 11:55 UTC
CompanyGe Healthcare
DistributionUS

Product

Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Reason

Additional low dose radiation exposure.

Identifiers

code_infoRevolution CT

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1951-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.