Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1642-2008

AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be...

Philips North America LLC / initiated 2008-03-14 / Terminated / root cause: design

Philips Medical Systems North America Co. Phillips began a recall of 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 on . The reason FDA records is "Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1642-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
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.
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Reason for recall
Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.
Root cause tag
design
FDA root cause
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.
Product codes and lots
Part number 9896 002 04432