IntelliVue MX100 patient monitors recalled over the potential for missed alarms
Philips North America is recalling the IntelliVue Patient Monitor MX100 over a potential issue where the monitors did not alarm.
What this means for you
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 Patient Monitor MX100, product number 867033, is being recalled. The device carries UDI-DI 00884838082595 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
- DHEA Test
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Category
- Medical Device — Patient monitor
- Affected units
- 17
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 (4)
- EAN: 616612786418
- SKU: O320
- UDI-DI: None
- Lot/Serial Number: All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 92 recalled by GET TESTED INTERNATIONAL AB 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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