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U.S. Department of Health and Human Services

Class 2 Device Recall CAS Medical Systems

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  Class 2 Device Recall CAS Medical Systems see related information
Date Initiated by Firm May 24, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 13, 2005
Recall Number Z-1023-04
Recall Event ID 29223
510(K)Number K962781  
Product Classification Monitor, Breathing Frequency - Product Code BZQ
Product Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
Code Information Serial Numbers:  0351320- through 0351369, 0413101through 0413107, 0413109,through 0413117, 0413119 through 0413125, 0413188, 0413452 through 0413501 through 0414477.
Recalling Firm/
CAS Medical Systems, Inc.
44 E Industrial Rd
Branford CT 06405-6507
For Additional Information Contact Ron Jeffrey
Manufacturer Reason
for Recall
Device may not alarm for %SpO2 value limit violations if a specific feature is enabled
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BZQ and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES