23
Jun
2004

Inc. Class II CAS Medical Systems

0

Company: CAS Medical Systems, Inc.
Date of Enforcement Report: 6/23/04
Class: II

PRODUCT
Cardio Respiratory Monitor with Oximax technology with software version 5.0, Model 511. Recall # Z-1023-04.

REASON
Device may not alarm for %SpO2 value limit violations if a specific feature is enabled.

CODE
Serial Numbers: 0351320- through 0351369, 0413101through 0413107, 0413109,through 0413117, 0413119 through 0413125, 0413188, 0413452 through 0413501 through 0414477.

RECALLING FIRM/MANUFACTURER
CAS Medical Systems, Inc., Branford, CT, by telephone and letter dated May 24, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
146 units.

DISTRIBUTION
Nationwide, Canada, and Taiwan.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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