CAS Medical Systems, Inc. Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
Brand
CAS Medical Systems, Inc.
Lot Codes / Batch Numbers
Serial Numbers: 0351320- through 0351369, 0413101through 0413107, 0413109, through 0413117, 0413119 through 0413125, 0413188, 0413452 through 0413501 through 0414477.
Products Sold
Serial Numbers: 0351320- through 0351369, 0413101through 0413107, 0413109,through 0413117, 0413119 through 0413125, 0413188, 0413452 through 0413501 through 0414477.
CAS Medical Systems, Inc. is recalling Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0 due to Device may not alarm for %SpO2 value limit violations if a specific feature is enabled. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device may not alarm for %SpO2 value limit violations if a specific feature is enabled
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, GA, IL, IN, ME, MI, MN, NH, NJ, NY, PA, TX, WV, DC
Page updated: Jan 10, 2026