Recall Z-1106-2025— Philips North America Llc

Name: FDA recall Z-1106-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-15

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2025-01-15. It names one FDA 510(k) clearance: K082583. Product: IntelliBridge EC10 Module. Model Number: 865115. Reason: 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..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2025-01-15
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K082583 — INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5Philips Medizinsysteme Boeblingen GmbH, Cardiac AN·cleared 2009-02-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IntelliBridge EC10 Module. Model Number: 865115

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.