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Terminated

Philips IntelliVue Measurement Module X1 Model: M3001A

FDA Recall Z-0853-2016 · Posted None

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeMHX
Date Initiated2016-01-04
Date Terminated2021-03-01
Product Quantity13,300

Reason for Recall

The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor

Firm Action

Philips Healthcare issued the Field Safety Notice on January 4, 2016, and informed customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Until your software is upgraded, please make sure that the ST Analysis is switched ON when using STE measurement in the Hexad 12-lead ECG Monitoring. This can be done by entering the ST Analysis Menu and select ST Analysis to On. For more detailed information, please refer to the Instructions for Use (IFU) of your host monitor or to the X2 Measurement Module IFU. Philips will provide a software correction free of charge. For further questions please call (978) 659-3000.

Root Cause

Software Design Change

Distribution Pattern

Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran ( Islamic Republic of ) Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Morocco, Myanmar(Burma) Netherlands Antilles, Norway, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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