Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
FDA device recall Z-1023-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- CAS Medical Systems, Inc.
- Reason for recall
- Device may not alarm for %SpO2 value limit violations if a specific feature is enabled
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BZQ
- Quantity affected
- 146 units
- Distribution
- CA, DC, IL, IN, GA, ME, MI, MN, NH, NJ, NY, PA, TX, WV. Foreign: Canada, Taiwan
- Date initiated
- 2004-05-24
- Date posted
- 2004-07-20
- Date terminated
- 2005-06-13
- Location
- Branford, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COROMETRICS MODEL 510 AND 511 MONITOR (K962781) | Ge Medical Systems Information Technologies | 1997-03-06 |