Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
This recall has been terminated (originally issued July 20, 2004).
- Company
- Cas Medical Systems, Inc.
- Recall Initiated
- May 24, 2004
- Posted
- July 20, 2004
- Terminated
- June 13, 2005
- Recall Number
- Z-1023-04
- Quantity
- 146 units
- Firm Location
- Branford, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Device may not alarm for %SpO2 value limit violations if a specific feature is enabled
Distribution
CA, DC, IL, IN, GA, ME, MI, MN, NH, NJ, NY, PA, TX, WV. Foreign: Canada, Taiwan
Lot / Code Info
Serial Numbers: 0351320- through 0351369, 0413101through 0413107, 0413109,through 0413117, 0413119 through 0413125, 0413188, 0413452 through 0413501 through 0414477.
Root Cause
Other
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.
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