Z-1023-04

Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0

Name: Z-1023-04 Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
Creator: CAS Medical Systems, Inc.
Published: 2004-05-24
License: https://open.fda.gov/license/

Cas Medical Systems, Inc. / initiated 2004-05-24 / Terminated

FDA source

CAS Medical Systems, Inc. began a recall of Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0 on 2004-05-24. The reason FDA records is "Device may not alarm for %SpO2 value limit violations if a specific feature is enabled". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1023-04
Status: Terminated
Initiated: 2004-05-24
Posted: 2004-07-20
Terminated: 2005-06-13
Recalling firm: Cas Medical Systems, Inc.
Product: Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
Product code: BZQ Monitor, Breathing Frequency
Reason for recall: Device may not alarm for %SpO2 value limit violations if a specific feature is enabled
FDA 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 in commerce: 146 units
Distribution: CA, DC, IL, IN, GA, ME, MI, MN, NH, NJ, NY, PA, TX, WV. Foreign: Canada, Taiwan
Product codes and lots: Serial Numbers: 0351320- through 0351369, 0413101through 0413107, 0413109,through 0413117, 0413119 through 0413125, 0413188, 0413452 through 0413501 through 0414477.

Product code BZQ

K962781Class IICorometrics Model 510 and 511 MonitorGe Medical Systems Information Technologies / cleared 1997-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)