IntelliBridge EC10 Module. Model Number: 865115 recallZ-1106-2025 · Philips North America Llc · initiated Jan 15, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
Philips began notifying consignees on about 01/15/2025 via certified letters titled URGENT Field Safety Notice and URGENT Medical Device Correction letters. Consignees were instructed to ensure that there is no interruption of the cable connection between the Hamilton ventilator and the EC10 Module or IntelliBridge I/O board before use, provide the notification to all affected personnel and customers if the devices have been further distributed, and to complete and return the response form provided. A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will upgrade your ED245 Driver from revision A.0 to revision A.1. Distributors were instructed to return the Response Form attached your contact information, send the attached URGENT Field Safety Notice to each customer to whom you have distributed any affected device as soon as possible and no later than 5 days, together with the Reply Card, perform a good faith effort to get the Response Form by following up with the customer with a minimum of three attempts, and if possible, using multiple contact methods, inform Philips about the responses received, and implement the Technical solution established by Philips as soon as available within the timeframe communicated by Philips and confirm to Philips the implementation in all affected products. In case a product is not corrected, inform Philips on the reason why the technical solution cannot be implemented.
Recall details
- Recall number
- Z-1106-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 15, 2025
- Posted by the FDA
- Feb 5, 2025
- Recalling firm
- Philips North America Llc
- Quantity
- 2,230 units
- Product code
- MHX
- FDA submissions
- K082583
- Distribution
- US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
Product description
IntelliBridge EC10 Module. Model Number: 865115
Code information (models, lots, serial numbers)
Show the full code information (27k characters)
Model Number: 865115. UDI-DI Number: (01)00884838015951(21). 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Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IntelliBridge EC10 ModulePhilips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96138).
- Z-1107-2025 · Open, ClassifiedIntelliVue Patient Monitor MX400. Model Number: 866060
- Z-1108-2025 · Open, ClassifiedIntelliVue Patient Monitor MX450. Model Number: 866062
- Z-1109-2025 · Open, ClassifiedIntelliVue Patient Monitor MX500. Model Number: 866064
- Z-1110-2025 · Open, ClassifiedIntelliVue Patient Monitor MX550. Model Number: 866066
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page