—#143571

Product

Philips IntelliVue Module Measurement X2 Model: M3002A

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K150310
Affected lot / code info: Software Revision: K.21.54 or L.00.96

Why it was recalled

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

Root cause (FDA determination)

Software Design Change

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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.

Timeline

Recall initiated: 2016-01-04
Terminated: 2021-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.