Recall Z-1242-2018— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-1242-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-01

Class III · Terminated

Class III FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2017-12-01, terminated 2018-08-29. It names one FDA 510(k) clearance: K062754. 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.. Reason: The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification..

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class III
Status: Terminated
Initiated: 2017-12-01
Terminated: 2018-08-29
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K062754 — GAS MODULE SE, MODEL 0998-00-0481-02Datascope Corp.·cleared 2006-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.