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U.S. Department of Health and Human Services

Class 2 Device Recall 740 Series Multiparameter Monitor

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 Class 2 Device Recall 740 Series Multiparameter Monitorsee related information
Date Initiated by FirmJune 24, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on August 05, 2010
Recall NumberZ-2203-2008
Recall Event ID 48666
510(K)NumberK033048 
Product Classification Patient Physiological Monitor with Arrhythmia Alarms - Product Code MHX
Product740 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.
Code Information Serial Numbers: 0809834-0823035
FEI Number 2244861
Recalling Firm/
Manufacturer		 CAS Medical Systems, Inc.
44 E Industrial Rd
Branford CT 06405-6507
For Additional Information ContactSAME
203-488-6056
Manufacturer Reason
for Recall		Software: Audible alarm may be silenced if changed from the factory setting
FDA Determined
Cause 2		Software change control
ActionCASMED 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 Commerce820 units
DistributionWorldwide Distribution --- including USA and countries of Canada, Jordan, UK, France, and Taipei.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MHX
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