—#69564

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.

FDA product code: IXI — Block, Beam-Shaping, Radiation Therapy
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041949
Affected lot / code info: Part number 9896 002 04432

Why it was recalled

Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

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.

Timeline

Recall initiated: 2008-03-14
Posted by FDA: 2008-09-01
Terminated: 2012-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69564. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.