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U.S. Department of Health and Human Services

Class 2 Device Recall Zenition 50

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  Class 2 Device Recall Zenition 50 see related information
Date Initiated by Firm December 02, 2021
Create Date February 17, 2022
Recall Status1 Open3, Classified
Recall Number Z-0647-2022
Recall Event ID 89437
510(K)Number K183101  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Zenition 50, Model #718096
Code Information Wireless Foot switch 3P : 459801238191  Wireless Foot switch 3P: 459801238231 
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
Manufacturer Reason
for Recall		 Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
FDA Determined
Cause 2		 Under Investigation by firm
Action On December 2, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. The Medical Device Correction includes the following instructions for the Customer: o Ensure that the wired foot switch is always connected to the system. o Immediately start using the wired foot switch or hand switch in the event the wireless foot switch loses connection. o Perform a daily check for damage and correct functioning of the hand switch and wired foot switch as described by the User Routine Checks section in your Instruction for Use. o Circulate this notice to all users of this device so that they are aware of the issue./ o Place this Medical Device Correction with the documentation of the Philips Zenition 50, Zenition 70 or Veradius Unity system. o Return the attached reply form to Philips to confirm that: 1. The Zenition 50, Zenition 70 and Veradius Unity systems wired foot switch is connected to the system 2. The users of the system have reviewed and understood this Medical Device Correction. If you need further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377.
Quantity in Commerce 16 US; 76 ROW
Distribution Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV
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