medical Class II Updated 2021-12-29

Philips North America Llc recalls Philips Allura Xper FD series with Software Version Number:

Recalled Product

Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.

Hazard / Issue

Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: US Serial Number/UDI: 1 (01)00884838054202(21)1; 527 (01)00884838059054(21)527; 408 (01)00884838054202(21)408; 306 (01)00884838054202(21)306; 61 (01)00884838059030(21)61 OUS: Model Product S/N UDI: 722006 Allura Xper FD20 1997 (01)00884838059191(10)1997; 722010 Allura Xper FD10 1177 (01)00884838059030(21)1177; 722010 Allura Xper FD10 1178 (01)00884838059030(21)1178; 722013 Allura Xper FD20 Biplane 544;; 722010 Allura Xper FD10 514 (01)00884838059030(21)514; 722013 Allura Xper FD20 Biplane 271; 722025 Allura Xper FD20 Biplane OR Table 6; 722005 Allura Xper FD10/10 519; 722008 Allura Xper FD20 Biplane 531; 722012 Allura Xper FD20 1901 (01)00884838059054(21)1901; 722012 Allura Xper FD20 2505 (01)00884838059054(21)2505; 722013 Allura Xper FD20 Biplane 137; 722026 Allura Xper FD10 439 (01)00884838054189(21)439; 722134 Field ext. Xper vascular systems R7.6 98736; 722027 Allura Xper FD10/10 172 (01)00884838054196(21)172;
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