FDA Device recall Z-2143-2018
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352 by Philips Electronics North America, citing five warning statements are missing from the instructions for use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2143-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-30 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Reason
Five warning statements are missing from the instructions for use.
Identifiers
| code_info | All devices since release of B.05 (March 2016) prefix date code >/= US096 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2143-2018%22
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