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.
FDA Recall Z-1242-2018 · Posted None
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Recalling FirmMindray DS USA, Inc. dba Mindray North America
Recall StatusTerminated
Product CodeBZK
Date Initiated2017-12-01
Date Terminated2018-08-29
Product Quantity1719
Reason for Recall
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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