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U.S. Department of Health and Human Services

Class 2 Device Recall Philips DigitalDiagnost Upgrades

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  Class 2 Device Recall Philips DigitalDiagnost Upgrades 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-2864-2018
Recall Event ID 80577
510(K)Number K090625  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product DigitalDiagnost Upgrades (Stitching Patient Support) 712083
Code Information Serial Numbers:  437736/SN09000282 491574/SN12000099 488712 415314/SN0902058 445533/SN10000006 414930/SN08000055 SN13000238 SN13000214 504759/SN12000356 487719/SN11000538 504766/SN12000207 SN14000264 SN14000264 469223/SN10000643 493888/SN12000004 316236 306773 306776 334582 325938 SN08000301 396570/SN0802320 SN08000216 
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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