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U.S. Department of Health and Human Services

Class 2 Device Recall Vertical drive brake

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  Class 2 Device Recall Vertical drive brake see related information
Date Initiated by Firm September 23, 2008
Date Posted January 16, 2009
Recall Status1 Terminated 3 on March 01, 2012
Recall Number Z-0597-2009
Recall Event ID 50120
510(K)Number K033357  K012009  K033326  K010817  
Product Classification System, x-ray, tomography, computed - Product Code KPS
Product Vertical 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 Contact John 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
Action A 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 Commerce 559
Distribution Worldwide 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 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 = KPS and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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