Recalls / —

—#198921

Product

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

FDA product code

OWB — Interventional Fluoroscopic X-Ray System

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K132147

Affected 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)

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern

Worldwide - US Nationwide distribution.

Timeline

Recall initiated

2023-02-20

Posted by FDA

2023-04-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #198921. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.