IntelliBridge EC10 Module may fail to alarm on ventilator disconnection
The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient 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: FDA Class II medical device recall involving potential failure of a critical alarm function. No illnesses or injuries reported; the hazard is theoretical. Per the severity rubric, theoretical hazards without reported illness score at most 3 (High).
Plain-English summary
The IntelliBridge EC10 Module (Model 865115) is being recalled by Philips North America LLC. The device may fail to generate an alarm for "No Device Data" when a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
An undetected ventilator disconnection could compromise patient monitoring. Approximately 2,230 units were affected.
Distribution included the United States (Florida, North Carolina, and Oregon) and internationally in Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, and the United Kingdom.
The recalled product
- Product
- IntelliBridge EC10 Module. Model Number: 865115
- Manufacturer
- Philips North America Llc
- Affected units
- 2,230
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 (20)
- DE57028993
- DE57028976
- DE57028982
- DE57028983
- DE57028987
- DE57028988
- DE57028951
- DE57028992
- DE57029001
- DE57029002
- DE57028989
- DE57028990
- DE57028991
- DE57029000
- DE61951169
- DE61951170
- DE61951171
- DE61951143
- DE61951141
- DE61951139
Distribution
Part of a larger recall action
This product is one of 5 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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