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.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Cas Medical Systems, Inc.
- Recall Initiated
- June 24, 2008
- Posted
- September 16, 2008
- Terminated
- August 5, 2010
- Recall Number
- Z-2203-2008
- Quantity
- 820 units
- Firm Location
- Branford, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Software: Audible alarm may be silenced if changed from the factory setting
Distribution
Worldwide Distribution --- including USA and countries of Canada, Jordan, UK, France, and Taipei.
Lot / Code Info
Serial Numbers: 0809834-0823035
Root Cause
Software change control
Action Taken
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.