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U.S. Department of Health and Human Services

Class 2 Device Recall Philips DigitalDiagnost 4 High Performance

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  Class 2 Device Recall Philips DigitalDiagnost 4 High Performance 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-2851-2018
Recall Event ID 80577
510(K)Number K090625  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
Code Information Serial Numbers:  SN17000294 SN17000295 SN17000114 SN17000185 SN17000362 SN17000263 SN17000264 SN17000399 SN15000017 SN17000235 SN18000001 SN17000414 SN17000376 SN16000352 SN17000311 SN17000070 SN14000079 SN14000080 SN17000044 SN17000346 SN14000052 SN17000045 SN17000351 SN17000038 SN17000262 SN17000126 SN15000122 SN17000100 SN17000422 SN17000359 SN16000390 SN15000048 SN17000084 SN16000386 SN17000106 SN17000288 SN17000278 SN17000335 SN16000394 SN16000387 SN17000151 SN17000352 SN17000329 SN17000349 SN17000303 SN17000334 SN17000216 SN17000305 SN17000398 SN15000328 SN17000289 SN17000411 SN17000436 SN17000090 SN15000006 SN17000179 SN17000034 SN17000231 SN16000355 SN17000166 SN17000127 SN16000421 SN16000398 SN14000105 SN16000430 SN16000418 SN17000150 SN17000092 SN15000054 SN15000097 SN15000110 SN17000373 SN15000132 SN14000040 SN14000045 SN15000098 SN16000435 SN15000142 SN15000151 SN17000141 SN15000410 SN15000417 SN16000402 
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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