| Class 2 Device Recall AD 7 Patient table | |
Date Initiated by Firm | March 14, 2008 |
Date Posted | September 01, 2008 |
Recall Status1 |
Terminated 3 on July 18, 2012 |
Recall Number | Z-1642-2008 |
Recall Event ID |
47487 |
510(K)Number | K041949 |
Product Classification |
Table - Product Code IXI
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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 WA 98021-8431
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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.
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FDA Determined Cause 2 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = IXI
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