Recall Z-2143-2018
Philips Electronics North America Corporation · initiated April 30, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Codes / lots: All devices since release of B.05 (March 2016) prefix date code >/= US096
Reason for recall
Five warning statements are missing from the instructions for use.
FDA-determined 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.
Details
- Recall number
- Z-2143-2018
- Initiated
- April 30, 2018
- Terminated
- October 4, 2019
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Quantity
- 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…
- Recalling firm
- Philips Electronics North America Corporation, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2141-2018 Class II | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350Five warning statements are missing from the instructions for use. | 04/30/2018Terminated |
| Z-2142-2018 Class II | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351Five warning statements are missing from the instructions for use. | 04/30/2018Terminated |
| Z-2144-2018 Class II | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146Five warning statements are missing from the instructions for use. | 04/30/2018Terminated |