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Open, Classified

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

FDA Recall Z-1417-2023 · Posted 2023-04-20

Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2023-02-20
Product Quantity549 units (75 US, 474 OUS)

Reason for Recall

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

Firm Action

A recall notification letter was issued February 20, 2023. The Urgent Medical Device Correction letter includes the following instructions for the Customer: " Stop using SmartPerfusion and 2D Perfusion. NOTE: This message does not impact (other parts of) the Philips Allura or Azurion systems or other tools within the Interventional Workspot. The Philips Allura and Azurion systems as well as other Interventional Workspot tools may continue to be used. " Place the Urgent Medical Device Correction Letter with the documentation of the system. " Circulate the notice to all users so that they are aware of the product issue. " Return the reply form attached to the Urgent Medical Device Correction letter to Philips to confirm that the users of the system have reviewed and understood it.

Root Cause

Software design

Distribution Pattern

Worldwide - US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1321472D PERFUSIONPhilips Medical Systems Nederland B.V. · 2013-12-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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