Recall Z-0861-2026 ยท DSI Detector And Alarm, Arrhythmia
Philips North America Llc
IntelliVue Patient Monitor MX100. Product Number: 867033.
| Date | Dec 2, 2025 (initiated Oct 31, 2025) |
| Status | Open, Classified |
| Reason | Potential issue where the IntelliVue monitors did not alarm. |
| Root cause | Use error |
| Action | An URGENT Medical Device Correction notice, dated 10/31/25, was mailed to customers and distributors. Distributors were notified of this correction and instructed to forward the provided recall notification to all consignees. Additionally, distributors are asked to include their contact information for consignees in the provided response form and perform a good faith effort for each customer to obtain a completed response form. Consignees are instructed to notify all users of this recall notification and forward the notice to all who need to be aware within their organization or where affe |
| Quantity | 1,913,441 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Botswana, Brazil, Brunei, Bulgaria, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Co |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extensio Philips Medizin Systeme Boeblingen GmbH, Oct 6, 2017 |