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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 Systemssee related information
Date Initiated by FirmMay 24, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 13, 2005
Recall NumberZ-1023-04
Recall Event ID 29223
510(K)NumberK962781 
Product Classification Monitor, Breathing Frequency - Product Code BZQ
ProductModel 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/
Manufacturer		 CAS Medical Systems, Inc.
44 E Industrial Rd
Branford CT 06405-6507
For Additional Information ContactRon Jeffrey
203-488-6056
Manufacturer Reason
for Recall		Device may not alarm for %SpO2 value limit violations if a specific feature is enabled
FDA Determined
Cause 2		Other
ActionCAS 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 Commerce146 units
DistributionCA, DC, IL, IN, GA, ME, MI, MN, NH, NJ, NY, PA, TX, WV. Foreign: Canada, Taiwan
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BZQ
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