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 Vertical drive brake

  • 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 Vertical drive brakesee related information
Date Initiated by FirmSeptember 23, 2008
Date PostedJanuary 16, 2009
Recall Status1 Terminated 3 on March 01, 2012
Recall NumberZ-0597-2009
Recall Event ID 50120
510(K)NumberK010817 K012009 K033326 K033357 
Product Classification System, x-ray, tomography, computed - Product Code KPS
ProductVertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners. The device is a vertical drive brake that controls the vertical position of a patient support system or couch. The patient support system is intended to be used to place the patient in the correct horizontal and vertical position in order to be scanned. The couch is an accessory product to a computed tomography scanner.
Code Information Assembly number 4535 664 98912.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information ContactJohn R. Miller
440-483-7600
Manufacturer Reason
for Recall		The product is being recalled because the patient support may travel downwards without being commanded to move.
FDA Determined
Cause 2		Process control
ActionA On 11/15/2007 & 6/6/2008 the firm sent Urgent Device Notification letters to their customers. They notified their customers that a Field Service Engineer will inspect and repair the brake system.
Quantity in Commerce559
DistributionWorldwide Distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV and countries of Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Egypt, England, France, Germany, Greece, China, India, Indonesia, Ireland, Iraq, Italy, Japan, Jordan, Korea, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, South Africa, South Korea, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
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 = KPS
510(K)s with Product Code = KPS
510(K)s with Product Code = KPS
-
-