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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 Open3, Classified
Recall Number Z-2843-2018
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:  SN15000196 SN15000180 SN15000282 SN15000281 SN15000192 SN15000189 
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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