Recall Z-1023-04 ยท BZQ Monitor, Breathing Frequency
CAS Medical Systems, Inc.
Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
| Date | Jul 20, 2004 (initiated May 24, 2004) |
| Status | Terminated |
| Reason | Device may not alarm for %SpO2 value limit violations if a specific feature is enabled |
| Root cause | Other |
| Action | CAS Medical notified customers by telephone and followed with letter dated 5/24/04, advising users of the problem and to turn off the StatsSeconds feature. |
| Quantity | 146 units |
| Distribution | CA, DC, IL, IN, GA, ME, MI, MN, NH, NJ, NY, PA, TX, WV. Foreign: Canada, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962781 | COROMETRICS MODEL 510 AND 511 MONITOR Ge Medical Systems Information Technologies, Mar 6, 1997 |