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GE Medical Systems China Co., Ltd. recalls F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Recalled October 11, 2023 · FDA recall Z-2656-2023 · GE Medical Systems China
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. · FDA Class II
Units
1638 units
Sold at
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.
Description
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.
Product
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Manufacturer(s)
GE Medical Systems China Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →