NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT ...

Published: February 11, 2026Recall ID: Z-1240-2026Category: devicesCountry: US

Reason for Recall / Hazard

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Field	Value
City	Malvern
State	PA
Event id	98206
Address 1	40 Liberty Blvd
Address 2	N/A
Code info	Material Number: 11330003; UDI-DI: 04056869263168; Serial Numbers: 127226, 127156, 127268, 127260, 127217, 127313, 127272, 127275, 127276, 127206, 127118, 127152, 127091, 127183, 127166, 127125, 127264, 127220, 127104, 127037, 127136, 127201, 127137, 127221, 127205, 127176, 127297, 127245, 127138, 127314, 127310, 127195, 127259, 127093, 127085, 127215, 127235, 127208, 127256, 127036, 127180, 127242, 127115, 127290, 127146, 127039, 127315, 127203, 127071, 127170, 127318, 127273, 127101, 127046, 127133, 127246, 127083, 127240, 127241, 127299, 127068, 127224, 127139, 127251, 127119, 127265, 127311, 127185, 127111, 127112, 127102, 127249, 127266, 127280, 127132, 127227, 127277, 258044, 127142, 127289, 127075, 127144, 127130, 127131, 127080, 127124, 127271, 127169;
Postal code	19355-1418
Report date	20260211
Product type	Devices
Product quantity	88 units
Reason for recall	To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Voluntary mandated	Voluntary: Firm initiated
Recall initiation date	20251219
Initial firm notification	Letter
Center classification date	20260203

Recalling FirmSiemens Medical Solutions USA, Inc
StatusOngoing
Risk LevelClass II
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.