ClearanceBrief
Recall Z-0424-03 ยท KPR System, X-Ray, Stationary

X-Cel X-Ray Corp

X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive, Crystal Lake, IL 60012

DateMar 5, 2003 (initiated Nov 12, 2002)
StatusTerminated
ReasonThe X-Ray system contained a defective X-Ray tube shield.
Root causeOther
ActionRecalled by telephone call on 11/19/2002, with follow-up visits and letters dated 2/27/03. The tube shields were replaced and the x-ray units were recertified.
Quantity3 units
DistributionNorthbrook, IL and Frankfort, IL
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.