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U.S. Department of Health and Human Services

Class 2 Device Recall DigitalDiagnost C50

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  Class 2 Device Recall DigitalDiagnost C50 see related information
Date Initiated by Firm December 21, 2018
Create Date September 20, 2019
Recall Status1 Terminated 3 on October 27, 2020
Recall Number Z-2498-2019
Recall Event ID 83654
510(K)Number K163410  
Product Classification System, x-ray, stationary - Product Code KPR
Product DigitalDiagnost C50, Stationary X-ray System
Code Information Product Number 712201  System Serial Number:  SN170053 SN180074
Recalling Firm/
Manufacturer		 Philips Healthcare
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Dusty Leppert, CHP
978-659-7892
Manufacturer Reason
for Recall		 During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected product, the actions you are required to take and the actions planned by Philips to correct the issue. If you need any or further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips plans to initiate a field corrective action that will install the required label(s). Philips will implement the correction at no cost to the customer.
Quantity in Commerce 2
Distribution Puerto Rico
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 = KPR and Original Applicant = PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
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