Device product
Philips IntelliVue Measurement Module X1 Model: M3001A
Z-0853-2016
Product summary
- Event
- Event 73209
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,300
- Official record key
device-enforcement:Z-0853-2016
Official wording
Reason: 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
Code information: Software Revision:K.21.54 or L.00.96
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.
Derived failure modes
-
Unknown
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