Mindray DS USA, Inc. dba Mindray North America: Medical Device Recall in 2018 - (Recall #: Z-1242-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: December 1, 2017

Date Posted: April 4, 2018

Recall Number: Z-1242-2018

Event ID: 79423

Reason for Recall:

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

Status: Terminated

Product Quantity: 1719

Code Information:

All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.

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.

Voluntary or Mandated:

Voluntary: Firm initiated