FDA-Device2023-10-11Class II
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
GE Medical Systems China Co., Ltd.
Hazard
There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Zealand, Oman, Poland, Qatar, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
Affected count
1638 units
Manufactured in
National Hi-Tech, No. 19 Changjiang Road; Dev. Zone, Wuxi, N/A, China
Products
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2656-2023Don't want to check this manually?
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