Z-0592-2019 Class II Ongoing
FDA device recall Z-0592-2019 was initiated by Philips Electronics North America Corporation on October 10, 2018 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 35469 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2018
- Initiation Date
- October 10, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35469 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
All devices manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)