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U.S. Department of Health and Human Services

Class 3 Device Recall Gas Module 3 monitoring spirometer

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  Class 3 Device Recall Gas Module 3 monitoring spirometer see related information
Date Initiated by Firm December 01, 2017
Create Date March 28, 2018
Recall Status1 Terminated 3 on August 29, 2018
Recall Number Z-1242-2018
Recall Event ID 79423
510(K)Number K062754  
Product Classification Spirometer, monitoring (w/wo alarm) - Product Code BZK
Product Gas Module 3 monitoring spirometer, Part Number: 115-030108-00

Product Usage:
The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.
Code Information All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Diane Arpino
201-995-8407
Manufacturer Reason
for Recall		 The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
FDA Determined
Cause 2		 Device Design
Action Mindray sent an Safety Notification letter dated December 1, 2017 to all customers. The letter identified the affected product, problem and actions to be taken. For question call 201-995-8407.
Quantity in Commerce 1719
Distribution Worldwide Distribution - U.S. Nationwide in the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY, including Puerto Rico and distributed to 30 foreign consignees.
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 = BZK and Original Applicant = DATASCOPE CORP.
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