Recall Z-1642-2008 ยท IXI Block, Beam-Shaping, Radiation Therapy
Philips Medical Systems North America Co. Phillips
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.
| Date | Sep 1, 2008 (initiated Mar 14, 2008) |
| Status | Terminated |
| Reason | Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041949 | ALLURA XPER FD10 Philips Medical Systems North America Co., Jul 30, 2004 |