# FDA recall Z-2144-2018

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2018-04-30.

## Product

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146

## Reason for recall

Five warning statements are missing from the instructions for use.

## 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; and, countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, German, Ghana, Greece, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, UAE, and Vietnam.

## Key facts

- **Recall number:** Z-2144-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-30
- **Report date:** 2018-06-20
- **Termination date:** 2019-10-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2144-2018

## Citation

> AI Analytics. FDA recall Z-2144-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2144-2018. Source: US FDA. Licensed CC0.

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