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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 TraumaDiagnostsee related information
Date Initiated by FirmApril 07, 2020
Create DateApril 28, 2020
Recall Status1 Terminated 3 on April 28, 2023
Recall NumberZ-1806-2020
Recall Event ID 85472
510(K)NumberK945278 
Product Classification System, x-ray, stationary - Product Code KPR
ProductPhilips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Code Information All serial numbers
FEI Number 1218950
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactSAME
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
ActionPhilips 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 Commerce346 units (5 US and 341 OUS)
DistributionWorldwide 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 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 = KPR
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