Philips IntelliVue MX40 Patient Monitor Speaker Volume Recall
Philips is recalling IntelliVue MX40 patient monitors because the speaker volume may be diminished or inaudible at altitudes above 4,500 feet.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a performance issue (speaker volume) that could affect monitoring but does not involve reported injuries or immediate life-threatening failure.
Plain-English summary
Philips Electronics North America Corporation is recalling 35,469 units of the IntelliVue MX40 Patient Monitor, including model numbers 865350, 865351, 865352, and 867146. The affected devices were manufactured or repaired between February 21, 2017, and August 22, 2018, and were distributed nationwide in the United States.
The recall is due to a potential issue where the device's speaker volume may be diminished or not audible when operating in Monitor Mode at altitudes greater than 4,500 feet. These devices may also intermittently display 'Speaker Malfunct INOP' messages after the Power On Self-Test. The issue is only apparent under these specific altitude and mode conditions.
Health care professionals using these monitors should be aware of the potential for reduced audio output at high altitudes. The source text does not specify a corrective action or contact information for the recall.
The recalled product
- 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 a
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 35,469
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- too many to list.)
Distribution
Distributed nationwide across the United States.
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