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.
FDA Recall Z-1642-2008 · Posted 2008-09-01
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Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIXI
Date Initiated2008-03-14
Date Terminated2012-07-18
Product Quantity39 units
Reason for Recall
Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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