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U.S. Department of Health and Human Services

Class 2 Device Recall Philips DigitalDiagnost Dual Detector

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  Class 2 Device Recall Philips DigitalDiagnost Dual 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-2858-2018
Recall Event ID 80577
510(K)Number K090625  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
Code Information Serial Numbers:  488713/SN11000577 488714/SN11000572 444623/SN10000136 480503/SN11000473 480504/SN11000478 410040/SN08000021 422832/SN09000061 462407/SN10000363 448130/SN10000008 464981/SN10000471 455752/SN10000200 454061/SN10000216 426292/SN09000386 455546/SN10000143 420090/SN09000018 474817/SN11000080 474238/SN11000042 461799/SN10000347 455621/SN10000163 471148/SN11000122 471147/SN11000120 482904/SN11000375 482905/SN11000373 482903/SN11000379 440249/SN09000347 481021/SN11000446 487808/SN11000526 441778/SN09000452 432989/SN09000285 478307/SN12000004 476338/SN12000026 476034/SN12000027 422536/SN09000199 486638/SN11000494 466808/SN10000464 462593/SN10000439 471150/SN10000660 478233/SN11000233 473897/SN11000165 482501/SN11000527 453200/SN10000133 456093/SN10000204 461979/SN10000701 461976/SN10000704 443093/SN09000454 445110/SN09000461 16750755 477524/SN11000434 475932/SN11000341 475866/SN11000350 451542/SN10000098 442534/SN09000423 443443/SN09000420 484558/SN11000525 479928/SN11000287 466029/SN10000420 472613/SN11000162 480061/SN11000474 453085/SN10000125 467927/SN10000713 450779/SN10000062 480881/SN11000274 476835/SN11000179 442005/SN10000298 444627/SN10000142 442310/SN10000149 478181/SN11000455 481142/SN11000318 467348/SN11000207 441637/SN09000354 441638/SN09000356 464863/SN10000533 464880/SN10000714 421977/SN09000115 449365/SN10000110 464755/SN10000391 430355/SN09000214 451543/SN10000100 
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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