Z-1106-2025Class II
IntelliBridge EC10 Module. Model Number: 865115
Philips North America LLC / initiated 2025-01-15 / Open, Classified / root cause: software
Philips North America Llc began a recall of IntelliBridge EC10 Module. Model Number: 865115 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-1106-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- IntelliBridge EC10 Module. Model Number: 865115
- Product code
- MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Reason for recall
- 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.
- Root cause tag
- software
- FDA root cause
- Software design
- Action
- 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.
- Quantity in commerce
- 2,230 units
- Distribution
- US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
- Product codes and lots
- Model Number: 865115. UDI-DI Number: (01)00884838015951(21). 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DE769A3328, DE769A3327, DE769A3326, DE769A3324, DE769A3320, DE769A3331, DE70168189, DE70168194, DE70168595, DE70168414, DE70168411, DE70168600, DE70168601, DE70168602, DE70168603, DE70168605, DE70168610, DE70168597, DE70168405, DE70168122, DE70168386, DE70168095, DE70168097, DE70168100, DE70168101, DE70168102, DE70168103, DE70168105, DE70168107, DE70168108, DE70168117, DE70168120, DE70168121, DE70168612, DE70168124, DE70168217, DE70168613, DE70168412, DE70168614, DE70175916, DE70175873, DE76995172, DE76995173, DE76995155, DE76995171, DE76997216, DE76997209, DE769A3001, DE769A3002, DE769A3006, DE769A3010, DE769A3012, DE769A3013, DE769A3016, DE769A3017, DE769A3015, DE769A3019, DE769A3018, DE769A3052, DE769A3054, DE769A3059, DE769A3043, DE769A3044, DE769A3046, DE769A3057, DE769A3058, DE769A3060, DE31716793, DE61948376, DE61948375, DE61948371, DE61948367, DE61948366, DE61949403, DE61949424, DE61949423, DE61949428, DE61949427, DE61949410, DE61949422, DE61949425, DE61949421, DE61949392, 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DE60839706, DE60839677, DE60839676, DE60839675, DE60839674, DE60839673, DE60839672, DE60839727, DE60839730, DE60839743, DE60839748, DE60839729, DE60843406, DE60843402, DE60843401, DE60843400, DE60843399, DE60843407, DE60843393, DE60843392, DE60843391, DE60843390, DE60843388, DE60843398, DE60843403, DE60843405, DE60843404, DE60843387, DE60843732, DE60843721, DE60843716, DE60843722, DE73784135, DE73784229, DE73784227, DE73787450, DE73787448, DE73787447, DE73787444, DE73787443, DE73787441, DE73787439, DE73787436, DE73787435, DE73787433, DE769A4849, DE769A4850, DE31725748, DE31725768, DE31725763, DE31725762, DE31725761, DE31725754, DE31725760, DE31725746, DE31725756, DE31725750, DE31725751, DE31725747, DE31725755, DE31725759, DE31725745, DE31725757, DE31720267, DE31720320, DE61950780, DE61950779, DE61950781, DE61950764, DE61950778, DE61950776, DE61950777, DE61950783.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1106-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1107-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1108-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1109-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1110-2025 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.