Device product

2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

Z-1417-2023

February 20, 2023

Class II

Product summary

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event: Event 91806
Status: Ongoing
Classification: Class II
Quantity: 549 units (75 US, 474 OUS)
Official record key: device-enforcement:Z-1417-2023

Official wording

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

Code information: 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)

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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