Z-1242-2018Class III

Gas Module 3 monitoring spirometer, Part Number: 115-030108-00

Name: Z-1242-2018 Gas Module 3 monitoring spirometer, Part Number: 115-030108-00
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2017-12-01
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2017-12-01 / Terminated / root cause: design

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of 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... on 2017-12-01. FDA classified it as Class III and gives the reason as "The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1242-2018
Classification: Class III
Status: Terminated
Initiated: 2017-12-01
Posted: 2018-03-28
Terminated: 2018-08-29
Recalling firm: Datascope Corp.
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.
Product code: BZK Spirometer, Monitoring (W/Wo Alarm)
Reason for recall: The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1242-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1242-2018	Class III	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28

Product code BZK

K062754Class IIGas Module Se, Model 0998-00-0481-02Datascope Corp. / cleared 2006-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)