← FDA ENFORCEMENT
Z-2153-2026Class II

GE Medical Systems, LLC

Recalling firm
GE Medical Systems, LLC
Product type
Device
Status
Ongoing
Report date
2026-05-20
Distribution
Worldwide - US Nationwide distribution.
Firm state
WI
Product quantity
10 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Data Integrity
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.

Product description

Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

Code / lot info

UDI-DI: 00840682123471; Serial Numbers: REVV82200058CN REVV82200046CN REVV82100016CN REVV82200014CN REVV82100027CN REVV82200047CN REVV82100031CN REVV82400010CN REVV82200017CN REVV82400005CN

Other recalls SPEQ maps to Data Integrity
2026-07-15Class IICMR SURGICAL LIMITED2026-07-15Class IIMedtronic MiniMed, Inc.2026-07-01Class IIIPG Medical Corporation2026-06-24Class IIMedtronic Navigation, Inc.-Boxborough
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.