IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
This recall has been terminated (originally issued April 30, 2018).
- Recall Initiated
- April 30, 2018
- Terminated
- October 4, 2019
- Recall Number
- Z-2142-2018
- Quantity
- 7,178
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
All devices since release of B.05 (March 2016) prefix date code >/= US096
Root Cause
Error in labeling
Action Taken
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.