CLASS III Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
Gas Module 3 monitoring spirometer recalled by Mindray DS USA
Mindray DS USA is recalling Gas Module 3 monitoring spirometer, distributed nationwide in the US. The recall was initiated on 1 Dec 2017 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1242-2018
- FDA event ID
- 79423
- Recalling firm
- Mindray DS USA, Mahwah, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Dec 2017
- FDA classified
- 28 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 1 Dec 2017 | Recall initiated by company | |
| 28 Mar 2018 | Classified by FDA | +117 days |
| 4 Apr 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Product as listed by the FDA
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.
Where it was 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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Is Gas Module 3 monitoring spirometer recalled?
Yes. Mindray DS USA recalled Gas Module 3 monitoring spirometer on 1 Dec 2017. The recall is Class III and its status is Terminated. Recall number Z-1242-2018.
Why was it recalled?
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Which lots are affected?
All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mindray DS USA
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hardware configuration of the BeneVision Central Monitoring recalled | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS II | The Anesthesia System is a device used to administer to recalled | Mindray DS USA | Packaging Defects | Nationwide |
| Device | CLASS II | The Anesthesia System is a device used to administer to recalled | Mindray DS USA | Packaging Defects | Nationwide |
| Device | CLASS II | BeneVision N1 Patient Monitor (N1) recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS II | Sevoflurane E_Vap.(Quik-Fil):used recalled by Mindray DS USA | Mindray DS USA | Packaging Defects | Nationwide |
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| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |