Philips IntelliVue Patient Monitor Software Configuration Disables Enhanced ECG Alarms
Philips patient monitors with Option CP2 software version P.01.01 were factory-configured incorrectly, leaving enhanced arrhythmia detection alarms disabled. Affected devices will not trigger yellow alarms for enhanced arrhythmia detection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is FDA Class II recall of a patient monitoring device where a critical function (arrhythmia detection alarms) is disabled due to incorrect factory configuration. Although no illnesses or injuries are reported in the source text, the disabled functionality poses a risk of harm in clinical settings.
Plain-English summary
Certain Philips IntelliVue Patient Monitor models (MX400, MX450, MX500, MX550) with software version P.01.01 and Option CP2 were configured incorrectly during manufacturing. The Enhanced ECG Capabilities provided by Option CP2 were not properly enabled in these devices. As a result, the monitors will not provide yellow alarms for enhanced arrhythmia detection.
This recall affects 153 units that were distributed outside the United States, specifically to Denmark, France, Germany, Japan, and the United Kingdom. The affected devices are identified by their specific serial numbers and UDI codes, which are listed by the manufacturer.
This recall was retrospectively reported, meaning it is being reported after the devices had already been distributed.
The recalled product
- Product
- IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066…
- Manufacturer
- Philips North America Llc
- Affected units
- 153
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 (2)
- UDI-DI: (01)00884838038769(21)
- (01)00884838038776(21)
Distribution
Distribution scope not specified by the agency.
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