SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
- Recall Initiated
- February 20, 2023
- Posted
- April 20, 2023
- Recall Number
- Z-1416-2023
- Quantity
- 1461 units (236 US, 1225 OUS)
Reason for Recall
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Distribution
Worldwide - US Nationwide distribution.
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
Root Cause
Software design
Action Taken
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.