United StatesThe affected products are the syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS software applications installed on SOMATOM X.ceed, NAEOTOM Alpha, NAEOTOM Alpha.Prime, and NAEOTOM Alpha.Pro CT systems; identifiers include material numbers 11330002, 11330003, 11549431, 10191100 with the listed UDI-DIs and serial numbers. They were recalled because the applications have not received FDA 510(k) clearance, and owners are instructed to remove the software applications from the affected CT systems.
What's being recalled
SOMATOM X.ceed 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
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Recalling firm: Siemens Medical Solutions USA, Inc, Malvern, PA, United States.
How to identify it
Material Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250; 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; Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046; Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;
The hazard
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)