Mindray DS USA, Inc. dba Mindray North America recalls Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device d…

Recall date

December 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1242-2018

FDA classification

Class III

Brand / firm

Mindray DS USA, Inc. dba Mindray North America

Sold / distributed

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.

Why it was recalled

The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.