PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Mode

Hazard

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Details from the source

Reason for recall: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. Distribution: US Nationwide distribution. Quantity: 3,341 units Lot/code info: 1. Model Numbers (UDI Numbers): 722063 ((01)00884838085275(21)56, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)3, (01)00884838085275(21)22, (01)00884838085275(21)153, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)19, (01)00884838085275(21)121, (01)00884838085275(21)18, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)17, (01)00884838085275(21)53, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)151, (01)00884838085275(21)137, (01)00884838085275(21)73, (01)00884838085275(21)150, (01)00884838085275(21)105, (01)00884838085275(21)129, (01)00884838085275(21)59, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)89, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)140, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)148, (01)00884838085275(21)55), 722221 ((01)00884838099203(21)93, (01)00884838099203(21)108, (01)00884838099203(21)101, (01)00884838099203(21)124, (01)00884838099203(21)4, (01)00884838099203(21)106, (01)00884838099203(21)151, (01)00884838099203(21)71, (01)00884838099203(21)105, (01)00884838099203(21)60,

UPC codes

00884838085275, 00884838099203, 00884838085282, 00884838099210, 00884838103276, 00884838099227, 00884838099234, 00884838110564, 00884838085350, 00884838099265, 00884838085367, 00884838099272

Source

Official record: FDA (Device enforcement) ↗

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