PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

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: 1461 units (236 US, 1225 OUS) Lot/code info: UDI: (01)00884838088566 SmartPerfusion 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 key: 459801530271 sw key SmartPerfusion

UPC codes

00884838088566, 459801530271

Source

Official record: FDA (Device enforcement) ↗

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