GE Medical Systems China Co., Ltd.: F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 1638 units Lot/code info: UDI/DI 010019527852408921, Serial Numbers: SUT23230108HA, SUT23230111HA, SUT23240034HA, SUT23240035HA, SUT23230106HA, SUT23230107HA, SUT23230109HA, SUT23230110HA, SUT23230112HA, SUT23230113HA, SUT23230114HA, SUT23240001HA, SUT23240002HA, SUT23240003HA, SUT23240004HA, SUT23240005HA, SUT23240006HA, SUT23240007HA, SUT23240008HA, SUT23240009HA, SUT23240010HA, SUT23240011HA, SUT23240012HA, SUT23240013HA, SUT23240014HA, SUT23240015HA, SUT23240016HA, SUT23240018HA, SUT23240019HA, SUT23240020HA, SUT23240021HA, SUT23240022HA, SUT23240023HA, SUT23240024HA, SUT23240025HA, SUT23240026HA, SUT23240027HA, SUT23240028HA, SUT23240029HA, SUT23240030HA, SUT23240032HA, SUT23230100HA, SUT23230101HA, SUT23230102HA, SUT23240017HA, SUT23240036HA, SUT23240037HA, SUT23240038HA, SUT23240039HA, SUT23240040HA, SUT23240042HA, SUT23240043HA, SUT23240044HA, SUT23240048HA, SUT23240049HA, SUT23240050HA, SUT23240051HA, SUT23240052HA, SUT23240053HA, SUT23240054HA, SUT23240055HA, SUT23240056HA, SUT23240057HA, SUT23240058HA, SUT23240059HA, SUT23240060HA, SUT23240061HA, SUT23240062HA, SUT23240063HA, SUT23240064HA, SUT23240065HA, SUT23240066HA, SUT23240067HA, SUT23240068HA, SUT23240069HA, SUT23240070HA, SUT23240071HA, SUT23240081HA, SUT23240082HA, SUT23240083HA, SUT23270053HA, SUT23270054HA, SUT23270057HA, SUT23270058HA, SUT23270059HA, SUT23270060HA, SUT23270061HA, SUT23270062HA, SUT23270063HA, SUT23270065HA, SUT23270066HA, SUT23270067HA, SUT23270068HA, SUT23270069HA, SUT23280003HA, SUT23280004HA, SUT23280005HA, SU

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.