IntelliVue MX40 Patient Monitor recall
IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever…
Why was IntelliVue MX40 Patient Monitor 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)
- Product
- IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever…
- Recalling firm
- Philips Electronics North America Corporation
- Quantity
- 35469 units
- Distribution
- US Nationwide distribution.
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)