IntelliVue MX40 Patient Monitor recall
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
Why was IntelliVue MX40 Patient Monitor recalled?
Five warning statements are missing from the instructions for use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All devices since release of B.05 (March 2016) prefix date code >/= US096
- Product
- IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
- Recalling firm
- Philips Electronics North America Corporation
- Quantity
- 7,178
- 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.
- Recall date
- June 20, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)