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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Diagnost, stationary radiographic system

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  Class 2 Device Recall Digital Diagnost, stationary radiographic system see related information
Date Initiated by Firm March 17, 2014
Date Posted April 24, 2014
Recall Status1 Terminated 3 on September 16, 2020
Recall Number Z-1503-2014
Recall Event ID 67859
510(K)Number K982795  
Product Classification Solid stae x-ray (flat panel/digital imager) - Product Code MBQ
Product Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
Code Information Units distributed from November 2006 through March 2014.
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.
FDA Determined
Cause 2		 Under Investigation by firm
Action On March 17, 2014, consignees were notified of the recall via letter. The letter explains what the issue is, actions firms can take to avoid or minimize the occurrence of the issue, and the actions planned by Philips to correct the issue. For further information or support concerning this issue, please contact your local Philips Representative. 1-800-722-9377
Quantity in Commerce 985 devices
Distribution Nationwide: US: AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico
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 = MBQ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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