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U.S. Department of Health and Human Services

Class 2 Device Recall Philips DigitalDiagnost Single Detector

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  Class 2 Device Recall Philips DigitalDiagnost Single Detector see related information
Date Initiated by Firm June 27, 2018
Date Posted August 17, 2018
Recall Status1 Terminated 3 on April 30, 2024
Recall Number Z-2863-2018
Recall Event ID 80577
510(K)Number K090625  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product DigitalDiagnost Single Detector (Stitching Patient Support) 712020
Code Information Serial Numbers:  399921/SN08000023 410038/SN08000091 402577/SN09000137 479651/SN11000391 443237/SN09000411 496881/SN12000104 489345/SN11000590 459498/SN10000231 483525/SN11000377 468302/SN10000537 485692/SN11000443 422533/SN09000072 450553/SN10000089 414087/SN08000100 472611/SN11000056 443235/SN09000450 481036/SN11000471 471070/SN10000695 471047/SN10000700 455221/SN10000251 460072/SN10000336 478109/SN11000327 475856/SN11000315 415754/SN08000063 443660/SN10000010 440700/SN10000030 440260/SN09000350 447603/SN09000468 448647/SN10000111 467487/SN11000085 467484/SN10000602 477526/SN11000311 490997/SN12000106 451267/SN10000104 445433/SN09000434 488711/SN11000615 470906/SN11000142 485620/SN12000002 448671/SN10000076 480052/SN11000286 480053/SN11000288 439920/SN09000329 412942/SN08000036 418438/SN08000110 431111/SN09000237 
Recalling Firm/
Manufacturer		 Philips Medical Systems Gmbh, DMC
Development And Manufacturing Ctr.
Rontgenstr. 24
Hamburg Germany
For Additional Information Contact Philips Service Engineer
40-50782110
Manufacturer Reason
for Recall		 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
FDA Determined
Cause 2		 Device Design
Action On June 27, 2018, Philips Medical Systems issued URGENT FIELD SAFETY NOTICES, Medical Device Recall letters to customers. Customers were encouraged to always check the right position of the hook and ensure that the hook is locked according tot he IFU. Press hook down until it is locked. Make sure that the hook is in position. A Philips Service Engineer will contact impacted customers as soon as the Field Action Kit is ready to be implemented. Should you need to communicate with Philips in regards to this program, please reference FCO-71200185. If you need further information or support concerning this issue, please contact your local Philips representative.
Distribution US Nationwide; International to 66 countries
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 = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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