IntelliVue X2 measurement servers recalled over a potential failure to alarm
Philips North America is recalling the IntelliVue Multi Measurement Server X2 over a potential issue where the monitors did not alarm.
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: Scored 3 under the risk-of-harm criterion: a monitor that fails to alarm can leave a patient event unannounced, and no injuries are reported.
Plain-English summary
The Philips IntelliVue Multi Measurement Server X2, product number M3002A, is being recalled. The device carries UDI-DI 00884838000261 and the action covers all serial numbers.
The recall follows a potential issue where the IntelliVue monitors did not alarm.
The record lists a quantity of 1,913,441 units for the action. Distribution was worldwide, including nationwide in the United States and to a large number of other countries. The FDA has classified the action as Class II.
A patient monitor that does not alarm may leave a change in a patient's condition unannounced to staff. The enforcement record reports no injuries. Facilities should follow Philips' instructions.
The recalled product
- Product
- IntelliVue Multi Measurement Server X2. Product Number: M3002A.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Patient monitor
- Affected units
- 1,913,441
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 (3)
- Product Number: M3002A
- UDI-DI: 00884838000261
- All Serial No.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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