Z-2143-2018Class II

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352

Name: Z-2143-2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Creator: Philips Electronics North America Corporation
Published: 2018-04-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-04-30 / Terminated / root cause: labeling and UDI

FDA source

Philips Electronics North America Corporation began a recall of IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352 on 2018-04-30. FDA classified it as Class II and gives the reason as "Five warning statements are missing from the instructions for use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2143-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-30
Posted: 2018-06-11
Terminated: 2019-10-04
Recalling firm: Philips North America LLC
Product: IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: Five warning statements are missing from the instructions for use.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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; 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.
Product codes and lots: All devices since release of B.05 (March 2016) prefix date code >/= US096

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2143-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2141-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-11
Z-2142-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-11
Z-2143-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-11
Z-2144-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-11

Product code DSI

K113125Class IIIntellivue Mx40 Patient MonitorPhilips Medical Systems / cleared 2011-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)