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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Diagnost 3.1.x. XRay system

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  Class 2 Device Recall Digital Diagnost 3.1.x. XRay system see related information
Date Initiated by Firm May 11, 2017
Create Date June 09, 2017
Recall Status1 Terminated 3 on July 10, 2018
Recall Number Z-2154-2017
Recall Event ID 77312
510(K)Number K141736  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Philips DigitalDiagnost 3.1.x X-Ray System
Code Information DigitalDiagnost Upgrade Release 3.1.x to 3.1.3
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-659-3000
Manufacturer Reason
for Recall		 During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
FDA Determined
Cause 2		 Software design
Action Philip's planned action to bring defect into compliance: 1. You will contact customers and initiate a software update to correct the issue that incorrectly notifies the user of the detectors being ready. 2. You will install the software/firmware and perform testing to ensure the software update was effective. 3.You will provide a customer notification letter that includes a statement that you will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2.Philips Healthcare will implement this CAP by November 10, 2017. If you need any further information or support concerning this Issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377. We apologize for any inconvenience this may cause and trust that this information is adequately addressing any concerns you may have.
Quantity in Commerce US - 132
Distribution USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI
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 DMC GMBH
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