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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 Recall
Vertical drive brake
see related information
Date Posted January 16, 2009
Recall Status1 Open
Recall Number Z-0597-2009
Recall Event ID 50120
Premarket Notification
510(K) Numbers
K010817  K012009  K033326  K033357 
Product Classification System, Tomography, Computed, Emission - 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, Ohio 44143-2131
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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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