Company: bioMerieux, Inc,
Date of Enforcement Report:8/2/2006
Class:lI
PRODUCT
a) Hamilton brand RAPHAEL Ventilator (Software Version 2.2x),
Recall # Z-1249-06;
b) Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS),
Recall # Z-1250-06;
c) Hamilton brand RAPHAEL Color Ventilator (Software Version 2.2xC, 2.2xCU),
Recall # Z-1251-06
REASON
Alarm Failure — Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system..
CODE
a), b) and c) Serial Numbers: 2975 to 5360
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hamilton Medical, Inc., Reno, Nevada, by a Medical Device Field Correction on June 1, 2006.
Manufacturer: Hamilton Medical AG, Bonaduz, Switzerland. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2385 units
DISTRIBUTION
Nationwide and Internationally