740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS,
FDA device recall Z-2203-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- CAS Medical Systems, Inc.
- Reason for recall
- Software: Audible alarm may be silenced if changed from the factory setting
- 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.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 820 units
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, Jordan, UK, France, and Taipei.
- Date initiated
- 2008-06-24
- Date posted
- 2008-09-16
- Date terminated
- 2010-08-05
- Location
- Branford, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 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 (K033048) | Cas Medical Systems, Inc. | 2004-06-01 |