Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2203-2008

740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T...

Cas Medical Systems, Inc. / initiated 2008-06-24 / Terminated / root cause: software

CAS Medical Systems, Inc. began a recall of 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... on . The reason FDA records is "Software: Audible alarm may be silenced if changed from the factory setting". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2203-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Cas Medical Systems, Inc.
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 CAS Medical Systems, Inc., Branford, Connecticut 06405 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.
Product code
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall
Software: Audible alarm may be silenced if changed from the factory setting
Root cause tag
software
FDA root cause
Software change control
Action
CASMED notified customers by a Product Correction Notification letter on 6/24/08 to advise of problem of the audible alarm and a software upgrade to correct the problem. The firm requests that the alarm volume not be adjusted from its factory set value to ensure that alarms sound correctly. Also, the letter states that if the volume needs to be adjusted, that customers needs to be sure that they only select two clicks above, or two clicks below the mid-point, and that there is a corresponding beep when you make your selection. Customers are asked to review the attached list of serial numbers that will need to be updated with new software and to then email the a contact at the firm once updates have been completed. All updates must be completed by August 31, 2008.
Quantity in commerce
820 units
Distribution
Worldwide Distribution --- including USA and countries of Canada, Jordan, UK, France, and Taipei.
Product codes and lots
Serial Numbers: 0809834-0823035