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U.S. Department of Health and Human Services

Class 2 Device Recall Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1

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  Class 2 Device Recall Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 see related information
Date Initiated by Firm March 23, 2015
Create Date November 11, 2015
Recall Status1 Terminated 3 on January 17, 2017
Recall Number Z-2383-2015
Recall Event ID 71838
510(K)Number K141736  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1


Product Usage:
The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
Code Information DigitalDiagnost
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		 The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal due to a defect in the Microsoft Windows 7 operating system.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips Healthcare sent an Urgent Field Safety Notice letter dated June 25, 2015 to customers. The letter identified the affected product, problem and actions to be taken. Philips plans to install a software upgrade in affected systems, which will eliminate this issue. Philips Healthcare Field Service Engineers will schedule an appointment with customers to install the software update. For questions contact your local philips representative.
Quantity in Commerce 62
Distribution US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada.
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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