Recall Z-1242-2018 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
Mindray DS USA, Inc. dba Mindray North America
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 intens
| Date | Dec 1, 2017 |
| Status | Terminated |
| Reason | The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062754 | GAS MODULE SE, MODEL 0998-00-0481-02 Datascope Corp., Nov 2, 2006 |