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U.S. Department of Health and Human Services

Class 2 Device Recall SmartPerfusion

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 Class 2 Device Recall SmartPerfusionsee related information
Date Initiated by FirmFebruary 20, 2023
Date PostedApril 20, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1416-2023
Recall Event ID 91806
510(K)NumberK181966 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductSmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
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
FEI Number 3002807880
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
Manufacturer Reason
for Recall		There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
FDA Determined
Cause 2		Software design
ActionA 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.
Quantity in Commerce1461 units (236 US, 1225 OUS)
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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