Recall Z-2143-2018 ยท DSI Detector And Alarm, Arrhythmia
Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
| Date | Apr 30, 2018 |
| Status | Terminated |
| Reason | Five warning statements are missing from the instructions for use. |
| Root cause | Error in labeling |
| Action | Urgent Medical Device Correction notification letters were distributed on 4/30/18. The notification included the following instructions: Customers were asked to please review the information provided in the letter with all members of their staff who need to be aware of its contents. The letter provides information on the missing warnings and instructions for actions to be taken. The enclosed MX40 IFU Errata Sheet must be attached to the first page of Chapter 6 of the Instructions for Use for ready reference. Complete and return the attached Customer Reply Form. |
| Quantity | 4,488 |
| Distribution | Worldwide Distribution -- US, to the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and to the territories of Guam and Puerto Rico; a |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113125 | INTELLIVUE MX40 PATIENT MONITOR Philips Medical Systems, Nov 17, 2011 |