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U.S. Department of Health and Human Services

Class 2 Device Recall Philips BuckyDiagnost ; Model: 704060/706037

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  Class 2 Device Recall Philips BuckyDiagnost ; Model: 704060/706037 see related information
Date Initiated by Firm August 19, 2014
Create Date December 03, 2015
Recall Status1 Terminated 3 on June 14, 2016
Recall Number Z-0364-2016
Recall Event ID 69090
510(K)Number K945278  
Product Classification System, x-ray, stationary - Product Code KPR
Product Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Code Information All patient support for stitching are affected.
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		 The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
FDA Determined
Cause 2		 Device Design
Action The Field Safety Notice FCO70600086 will be mailed on August 19, 2014. Philips Medical Systems will send out certified letters and will have the receipts returned for tracking purposes as well as have a Field Service Engineer visit each site to provide the fix when the Field Change Order is released.
Quantity in Commerce 1517 systems, not all units have the patient support accessory
Distribution Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.
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 MEDICAL SYSTEMS NORTH AMERICA, INC.
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