Siemens Medical Solutions USA, Inc: NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Hazard

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

Details from the source

Reason for recall: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel. Quantity: 88 units Lot/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;

UPC codes

04056869263168

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.