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U.S. Department of Health and Human Services

Class 2 Device Recall Philips TraumaDiagnost

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  Class 2 Device Recall Philips TraumaDiagnost see related information
Date Initiated by Firm April 07, 2020
Create Date April 28, 2020
Recall Status1 Terminated 3 on April 28, 2023
Recall Number Z-1806-2020
Recall Event ID 85472
510(K)Number K945278  
Product Classification System, x-ray, stationary - Product Code KPR
Product Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact SAME
978-659-3000
Manufacturer Reason
for Recall		 If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
FDA Determined
Cause 2		 Device Design
Action Philips issued Urgent Field Safety Notice (FCO72000015) sent 4/09/20 via certified mail states reason for recall health risk, action to take: The IfU (Instruction for Use) require the operator to not use the system and call for service, if a mechanical defect or malfunction is suspected. As soon as a deformation is determined, the system may no longer be used and call the service engineer. Should you feel uncertain regarding these instructions, please contact Philips. If you would like any further information or support concerning this issue, please contact your local Philips representative.
Quantity in Commerce 346 units (5 US and 341 OUS)
Distribution Worldwide distribution - US Nationwide distribution including the states of CA, ME, RI, TX, WI and the countries of Canada, Australia, Austria, France, Germany, Greece, Hungary, Ireland, Netherlands, Portugal, Slovenia, United Kingdom.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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