ClearanceBrief
Recall Z-0270-04 ยท KPR System, X-Ray, Stationary

Philips Medical Systems Sales & Service Region No. America

Digital Diagnost VE

DateDec 24, 2003 (initiated Nov 20, 2003)
StatusTerminated
ReasonThe support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.
Root causeOther
ActionThe firm mailed a recall letter to affected customers on November 20, 2003 notifying them of the problem. The letter states upgrades will be completed by the end of April 2004.
Quantity70 devices total
DistributionThe firm distributed to medical facilities nationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.