PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

Hazard

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

Details from the source

Reason for recall: There are technical issues related to signal generation and processing, which can lead to inaccurate presentations. Distribution: Worldwide - US Nationwide distribution. Quantity: 549 units (75 US, 474 OUS) Lot/code info: UDI: (01)00884838059276 2D Perfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software License Keys: 459801071511 sw key 2D Perfusion (IW) 459800240601 sw key 2D Perfusion (XV)

UPC codes

00884838059276, 459801071511, 459800240601

Source

Official record: FDA (Device enforcement) ↗

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