Company: CAS Medical Systems, Inc,
Date of Enforcement Report 9/24/2008
Class:ll
PRODUCT
740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN. Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals, Recall # Z-2203-2008p>
REASON
Software: Audible alarm may be silenced if changed from the factory setting.
RECALLING FIRM/MANUFACTURER
CAS Medical Systems, Inc., Branford, CT, by letter on June 24, 2008, Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
820 units
DISTRIBUTION
Nationwide, Canada, Jordan, UK, France and Taipei