Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Philips BuckyDiagnost ; Model: 704060/706037see related information
Date Initiated by FirmAugust 19, 2014
Create DateDecember 03, 2015
Recall Status1 Terminated 3 on June 14, 2016
Recall NumberZ-0364-2016
Recall Event ID 69090
510(K)NumberK945278 
Product Classification System, x-ray, stationary - Product Code KPR
ProductPatient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Code Information All patient support for stitching are affected.
FEI Number 1218950
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
ActionThe 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 Commerce1517 systems, not all units have the patient support accessory
DistributionDistributed 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 CycleTPLC 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) Database510(K)s with Product Code = KPR
-
-