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U.S. Department of Health and Human Services

Class 2 Device Recall Philips DigitalDiagnost 4.1 High Performance

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  Class 2 Device Recall Philips DigitalDiagnost 4.1 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-2855-2018
Recall Event ID 80577
510(K)Number K090625  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product DigitalDiagnost 4.1 High Performance
(Stitching Patient Support) 712031
Code Information Serial Numbers:  SN15000291 SN16000158 SN15000374 SN15000298 SN16000191 SN15000327 SN17000317 SN16000321 SN16000063 SN15000364 SN15000444 SN16000143 SN15000443 SN16000037 SN15000371 SN15000303 SN16000137 SN16000329 SN16000095 SN16000308 SN16000328 SN16000043 SN16000151 SN15000442 SN16000147 SN16000146 SN16000050 SN16000271 SN16000253 SN16000073 SN16000296 SN16000297 SN16000311 SN16000263 SN16000371 SN16000214 SN16000142 SN16000025 SN16000165 SN16000105 SN15000264 SN16000264 SN16000302 SN16000113 SN16000112 SN16000123 SN15000373 SN15000165 SN16000347 SN16000375 SN15000355 SN16000225 
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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