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Class 3 Device Recall Gas Module 3 monitoring spirometer |
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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
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Product Classification |
Spirometer, monitoring (w/wo alarm) - Product Code BZK
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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.
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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
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For Additional Information Contact |
Diane Arpino 201-995-8407
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Manufacturer Reason for Recall |
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
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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
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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.
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510(K) Database |
510(K)s with Product Code = BZK and Original Applicant = DATASCOPE CORP.
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