ClearanceBrief
Recall Z-0369-05 ยท KPR System, X-Ray, Stationary

Philips Medical Systems Sales & Service Region No. America

Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811

DateDec 24, 2004 (initiated Dec 1, 2004)
StatusTerminated
ReasonX-Ray system may fall downward and could possibly hit the patient.
Root causeOther
ActionA notification was sent to all customers via certified mail, return receipt requested starting on December 1, 2004. Field Service Engineers will contact the customers to schedule a time for the column exchange starting mid-November and to be completed no later than Mid June 2005.
Quantity44 total units (Thoravision I and II)
DistributionThe firm distributed this product to hospitals and medical centers nationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K931071PHILIPS THORAVISION
Philips Medical Systems, Inc., Sep 15, 1994
K981657PHILIPS THORAVISION
Philips Medical Systems North America, Inc., Jun 18, 1998