Class 2 Device Recall IntelliBridge EC10 Module

• Date Initiated by Firm: January 15, 2025
• Date Posted: February 05, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1106-2025
• Recall Event ID: 96138
• 510(K)Number: K082583
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: IntelliBridge EC10 Module. Model Number: 865115
• Code Information: Model Number: 865115. UDI-DI Number: (01)00884838015951(21). 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• FEI Number: 3016618143
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MHX