FDA Medical Device Recalls (openFDA)
CAS Medical Systems, Inc.: Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
- Recall number
- Z-1023-04
- Recalling firm
- CAS Medical Systems, Inc.
- Product
- Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
- Status
- Terminated
- Initiated
- 2004-05-24
- Posted
- 2004-07-20
- Terminated
- 2005-06-13
- 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
- Lot, serial or model codes
- Serial Numbers: 0351320- through 0351369, 0413101through 0413107, 0413109,through 0413117, 0413119 through 0413125, 0413188, 0413452 through 0413501 through 0414477.
- 510(k) numbers
- ["K962781"]
- PMA numbers
- not on file
- Product code
- BZQ
- Firm FEI
- 2244861
- Firm city
- Branford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28