Device recall: IntelliBridge EC10 Module. Model Number: 865115
Class II FDA enforcement event 96138. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II, in the words of FDA
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
Philips North America Llc started this device recall on 15 Jan 2025. The firm address in the FDA record is in Cambridge, MA. FDA put the recall in Class II. FDA event 96138 has 5 product records. The first FDA enforcement report date is 12 Feb 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
Recalling firm
Philips North America Llc, Cambridge, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1106-2025 | IntelliBridge EC10 Module. Model Number: 865115 | 2,230 units | Class II | Ongoing | 12 Feb 2025 |
| Z-1107-2025 | IntelliVue Patient Monitor MX400. Model Number: 866060 | 28 units | Class II | Ongoing | 12 Feb 2025 |
| Z-1108-2025 | IntelliVue Patient Monitor MX450. Model Number: 866062 | 98 units | Class II | Ongoing | 12 Feb 2025 |
| Z-1109-2025 | IntelliVue Patient Monitor MX500. Model Number: 866064 | 45 units | Class II | Ongoing | 12 Feb 2025 |
| Z-1110-2025 | IntelliVue Patient Monitor MX550. Model Number: 866066 | 74 units | Class II | Ongoing | 12 Feb 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 5Median of the firm: 1
- Events of the firm on the register
- 129
Other events of the firm
Official channels
- FDA enforcement report Z-1106-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 96138. https://recallregister.com/fda/ii/96138/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
- What quantity of product is in FDA event 96138?
- The event has 5 product records. The first record gives this quantity:
2,230 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.