Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0424-03

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

X-Cel X-Ray Corp / initiated 2002-11-12 / Terminated

X-Cel X-Ray Corp began a recall of X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive, Crystal Lake, IL 60012 on . The reason FDA records is "The X-Ray system contained a defective X-Ray tube shield". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0424-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
X-Cel X-Ray Corp
Product
X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive, Crystal Lake, IL 60012
Product code
KPR--
Reason for recall
The X-Ray system contained a defective X-Ray tube shield.
FDA root cause
Other
Action
Recalled 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.
Quantity in commerce
3 units
Distribution
Northbrook, IL and Frankfort, IL
Product codes and lots
Model MB-700 A/C, srial numbers 622686, 622687, 622688, 622689, 320367, 325120