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Recall Observatory FDA recall evidence

Device product

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

Z-1416-2023

February 20, 2023

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event
Event 91806
Status
Ongoing
Classification
Class II
Quantity
1461 units (236 US, 1225 OUS)
Official record key
device-enforcement:Z-1416-2023

Official wording

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

Code information: 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

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.