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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare DigitalDiagnost

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  Class 2 Device Recall Philips Healthcare DigitalDiagnost see related information
Date Initiated by Firm November 10, 2015
Date Posted June 03, 2016
Recall Status1 Terminated 3 on May 03, 2017
Recall Number Z-1695-2016
Recall Event ID 74083
510(K)Number K141736  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Philips Healthcare DigitalDiagnost stationary X-ray system
Code Information software version - 4.0.4, 4.1.2, 4.1.3.
Recalling Firm/
Philips Healthcare
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
Manufacturer Reason
for Recall
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call 1-800- 722-9377.
Quantity in Commerce 160
Distribution USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
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