Philips IntelliVue Patient Monitors Recalled for Distorted ST-Segment Display
Philips is recalling specific IntelliVue patient monitors and measurement servers because they may display distorted ST-segments during 12-lead ECG monitoring.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (distorted ECG readings) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling 7,071 units of IntelliVue Multi Measurement Servers and IntelliVue Patient Monitors (Models MP2 and MP5). The affected devices include specific models such as M300IA/AL, M3002A, M8102A, and M8105A, equipped with specific firmware revisions and the 12-lead option.
The recall is due to a defect where the devices may display a distorted ST-segment when used for 12-lead ECG monitoring. This issue could potentially affect the accuracy of the physiological parameter monitoring intended for adults, pediatrics, and neonates in hospital environments.
The affected units were distributed worldwide and nationwide in the US. Health care professionals using these devices should check their equipment against the specific model numbers and firmware revisions listed in the recall notice to determine if they are affected.
The recalled product
- Product
- IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the…
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Affected units
- 7,071
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 (7)
- Model #: M300IA/AL
- M3002A
- M8102A
- 866462 (M3001AL)
- 865039 (M3002A)
- 865040 (M8102A)
- 865024 (M8105A)
Distribution
Distributed nationwide across the United States.
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