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U.S. Department of Health and Human Services

Class 2 Device Recall AD 7 Patient table

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 Class 2 Recall
AD 7 Patient table
see related information
Date Posted September 01, 2008
Recall Status1 Open
Recall Number Z-1642-2008
Recall Event ID 47487
Premarket Notification
510(K) Number
K041949 
Product Classification Block, Beam-Shaping, Radiation Therapy - Product Code IXI
Product AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option.
Code Information Part number 9896 002 04432
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall
Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.
FDA Determined
Cause 2
DESIGN: Device Design
Action On 03/22/2004, firm sent letters via certified mail to notify customers of issue. Letter advises customers of potential risk for patients and users, and states to not use system for critical examinations or treatments if table movements suddenly stops or makes a freeing movement. The letter indicates a representative will contact customer for installation of a Hardware filter, free of charge, to prevent Electromagnetic interference (EMI) from affecting the force sensor. Please contact Philips at 1-800-722-9377 #5, #4, #1.
Quantity in Commerce 39 units
Distribution Product is distributed to hospitals and medical centers nationwide to the following states: ND, FL, KY, MN, VA, ME, PA, NJ, CT, TX, CA, OH, TN, OR, GA, NY, SC, MO, WA, IL.
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 = IXI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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