Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Zenition 50

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Zenition 50see related information
Date Initiated by FirmApril 10, 2020
Create DateMay 08, 2020
Recall Status1 Terminated 3 on January 11, 2021
Recall NumberZ-1932-2020
Recall Event ID 85473
510(K)NumberK183101 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductPhilips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
Code Information Serial Numbers 17 7 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactTechnical Support
800-722-9377
Manufacturer Reason
for Recall		When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.
FDA Determined
Cause 2		Device Design
ActionOn April 10, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed of the product issue. Customers were asked to do the following: - Ensure that Cabling Check and Connectors Check are performed daily, as indicated in the User Routine Checks Program (section 7.4 of the Instructions for Use provided with the system). - In case the strain relief is lost and/or damage to the cable/connector is identified; stop using the system and contact your Philips local representative so that the cable can be replaced. - Please ensure that all staff working with the system are informed of the content of this safety notice and place a copy of it with the Instructions for Use. Philips will be replacing the Stand MVS Trolley Cable (459800943703) in all affected systems by a new Stand MVS Trolley Cable that has an improved strain relief design. This action will start by end of April 2020. You will be contacted by a local Philips representative to schedule an appointment to replace the cable. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377
Quantity in Commerce25 total
DistributionWorldwide distribution - US Nationwide distribution including in the states of MD and MI. The countries of Austria, Belgium, France, Germany, Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
-
-