Class 2 Device Recall CAS Medical Systems

• Date Initiated by Firm: May 24, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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/ Manufacturer: CAS Medical Systems, Inc.; 44 E Industrial Rd; Branford CT 06405-6507
• For Additional Information Contact: Ron 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: 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
• 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