Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: ...

FDA Device Recall #Z-0292-2017 — Class II — September 19, 2016

Recall Summary

Recall Number Z-0292-2017
Classification Class II — Moderate risk
Date Initiated September 19, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Electronics North America Corporation
Location Andover, MA
Product Type Devices
Quantity 1824 units

Product Description

Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwide except for the USA SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals

Reason for Recall

Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX

Distribution Pattern

Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.

Lot / Code Information

SW Revisions: B.05.28, B.05.29, and B.05.32

Other Recalls from Philips Electronics North America Co...

Recall # Classification Product Date
Z-0614-2019 Class II Xper Flex Cardio Physiomonitoring System, Softw... Nov 15, 2018
Z-0592-2019 Class II IntelliVue MX40 Patient Monitor, Model Nos. 865... Oct 10, 2018
Z-3227-2018 Class II Allura Xper F010, System Code 722003 Vascul... Jul 16, 2018
Z-3218-2018 Class II INTEGRIS SUITE, System Code 722199 Vascular... Jul 16, 2018
Z-3215-2018 Class II INTEGRIS CV, System Code 722030 Vascular, c... Jul 16, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.