Reported Dec 19, 2018 · Ongoing
IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health…
Philips Electronics North America Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
IntelliVue MX40 Patient MonitorModel Nos. 865350865351865352867146 -
- Product UsageIndicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals
- Lot codes and dates
- All devices manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)
- Amount recalled
- 35469 units
Where it was sold
- Nationwide
Why it was recalled
A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-Test. The issue is only apparent when the device is being used in Monitor Mode at an altitude of greater than 4,500 feet.
This product could cause temporary or reversible health problems — stop using it.
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