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U.S. Department of Health and Human Services

Class 2 Device Recall Philips DuraDiagnost (R1.0 product 712210, R2.0 product 712211, and R3.0 product 712211)

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 Class 2 Device Recall Philips DuraDiagnost (R1.0 product 712210, R2.0 product 712211, and R3.0 product 712211)see related information
Date Initiated by FirmMay 31, 2017
Create DateJune 09, 2017
Recall Status1 Terminated 3 on August 24, 2018
Recall NumberZ-2322-2017
Recall Event ID 77410
510(K)NumberK141381 
Product Classification System, x-ray, stationary - Product Code KPR
ProductPhilips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
Code Information SN120001-SN120003, SN130001-SN130023, SN140001-SN140022, SN140024, SN140027, SN140030-SN140031, SN140033-SN140046, SN140048, SN140050-SN140068, SN150001-SN150004, SN150006, SN150008-SN150011, SN160001, SN160002
FEI Number 1218950
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactSAME
978-659-3000
Manufacturer Reason
for Recall		Tube arm assembly could fall down due to cracked welding joints
FDA Determined
Cause 2		Device Design
ActionPhilips Healthcare sent an URGENT - Field Safety Notice Medical Device Correction letter dated May 23, 2017, advising users of the problem and asking facilities to stop using the device until a Philips Engineer can go on-site to perform the FC071200173; contact your local Philips representative if you have any concern or support required on this issue. If you need any further information or support concerning this issue, contact your local Philips representative. For further questions, please call (978) 659-3000.
Quantity in Commerce98 sytems
DistributionWorldwide Distribution - US Distribution to the states of : Ca and Oh., and to the countries of: Australia, Libya, China, Mayotte, Mexico, France, United Kingdom, Germany, Ecuador, Australia, Spain, Switzerland, Macedonia, Uzbekistan, Kuwait, Malaysia, Netherlands, Argentina, Chile, Colombia, Egypt, United Arab Emirates, Saudi Arabia, Hungary, Peru, Poland, Indonesia, Burkina Faso, Kazakhstan, Turkey and Slovenia.
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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