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FDA (Device enforcement)Recalled 2026-06-17class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xp

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: 5,012 units Lot/code info: 1. Allura Xper FD10; Model Numbers (UDI Numbers): 722003 (N/A), 722010 ((01)00884838059030(21)754, (01)00884838059030(21)42, (01)00884838059030(21)500, (01)00884838059030(21)68, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)585, (01)00884838059030(21)641, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)667, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)359, (01)00884838059030(21)423, (01)00884838059030(21)1040, (01)00884838059030(21)478, (01)00884838059030(21)215, (01)00884838059030(21)1298, (01)00884838059030(21)970, (01)00884838059030(21)1226, (01)00884838059030(21)365, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1275, (01)00884838059030(21)755, (01)00884838059030(21)671, (01)00884838059030(21)677, (01)00884838059030(21)61, (01)00884838059030(21)477, (01)00884838059030(21)1078, (01)00884838059030(21)327, (01)00884838059030(21)65, (01)00884838059030(21)1369, (01)00884838059030(21)792, (01)00884838059030(21)679, (01)00884838059030(21)479, (01)00884838059030(21)485, (01)00884838059030(21)592, (01)00884838059030(21)229, (01)00884838059030(21)119, (01)00884838059030(21)662, (01)00884838059030(21)1235, (01)00884838059030(21)1214, (01)00884838059030(21)764, (01)00884838059030(21)902, (01)00884838059030(21)1344, (01)00884838059030(21)675, (01)00884838059030(21)191, (01)008848380590

UPC codes

00884838059030, 00884838054189, 00884838054233, 00884838059047, 00884838054196

Source

Official record: FDA (Device enforcement)

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

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