FDA Medical Device Recalls (openFDA)
Philips Electronics North America Corporation: IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated 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.
- Recall number
- Z-0592-2019
- Recalling firm
- Philips Electronics North America Corporation
- Product
- IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated 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.
- Status
- Open, Classified
- Initiated
- 2018-10-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Vendor change control
- Action
- On November 9, 2018, the firm notified customers of the issue via Customer Information Letters. The letter discussed the product problem. Customers are asked to confirm speaker behavior. It is recommended that the clinical user reboot the MX40 prior to entering Monitoring Mode to confirm proper operation of the speaker. Customers are also asked to complete the attached Reply Card and return to Philips as soon as possible. The firm will replace affected devices used at above 4,500 feet (1,372 meters). If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377.
- Quantity
- 35469 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- All devices manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)
- 510(k) numbers
- ["K113125"]
- PMA numbers
- not on file
- Product code
- DSI
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28