Data Foundry

Medical device recalls 2026

Revolution Ascend — Class II medical device recall Z-2149-2026

Ongoing recall by GE Medical Systems, LLC, reported 2026-05-20, distributed nationwide. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison H

Recall numberZ-2149-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGE Medical Systems, LLC, Waukesha, WI, United States
Recall initiated2026-03-26
Classified2026-05-08
Reported by FDA2026-05-20
DistributedNationwide (US)
Quantity25 units
UPC / GTIN / UDI-DI00840682146173
Serial numbersAS10G2100008YC, AS10G2200035YC, AS10G2200068YC, AS10G2200085YC, AS10G2200101YC, AS10G2200136YC, AS10G2300041YC, AS10G2300057YC, AS10G2300093YC, AS10G2400056YC, AS10G2400079YC, AS10G2400081YC, AS10G2400087YC, AS10G2400094YC, AS10G2500002YC, CBDWG2300041HM, CBDWG2300056HM, CBDWG2300081HM, CBDWG2400019HM, CBDWG2400085HM, CBDWG2400117HM, CBDWG2400126HM, CBDWG2400140HM, CBDWG2500003HM, CBDWG2500011HM
Model numbers6969000-100, 6969000-300

Product

Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

Reason for recall

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

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-2149-2026. 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.