Recalls / —
—#164321
Product
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
- FDA product code
- DSI — Detector And Alarm, Arrhythmia
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K113125
- Affected lot / code info
- All devices since release of B.05 (March 2016) prefix date code >/= US096
Why it was recalled
Five warning statements are missing from the instructions for use.
Root cause (FDA determination)
Error in labeling
Action the firm took
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.
Recalling firm
- Firm
- Philips Electronics North America Corporation
- Address
- 3000 Minuteman Rd, Andover, Massachusetts 01810-1032
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2018-04-30
- Terminated
- 2019-10-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #164321. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.