Recall Z-2203-2008 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CAS Medical Systems, Inc.
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, pediatri
| Date | Sep 16, 2008 (initiated Jun 24, 2008) |
| Status | Terminated |
| Reason | Software: Audible alarm may be silenced if changed from the factory setting |
| 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 number |
| Quantity | 820 units |
| Distribution | Worldwide Distribution --- including USA and countries of Canada, Jordan, UK, France, and Taipei. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033048 | CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS Cas Medical Systems, Inc., Jun 1, 2004 |