GE Medical Systems China recalls F2-01 Frame patient monitors with arrhythmia detection or alarms due to potential data communication interruption if not powered down within 120 days.
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.
GE Medical Systems China is recalling F2-01 Frame patient monitors with arrhythmia detection or alarms. The recall is due to a potential interruption in data communication between E-modules and patient monitors if the frame has not been powered down within the last 120 days. This could affect patient monitoring accuracy.
If the F2-01 Frame has not been powered down within the last 120 days, there is a potential interruption in data communication between the E-modules and the CARESCAPE ONE or CARESCAPE Canvas 1000 patient monitors. This could lead to inaccurate patient monitoring readings.
Healthcare providers using the F2-01 Frame patient monitors with arrhythmia detection or alarms are most at risk. The recall affects specific serial numbers listed in the official notice.
Check the serial numbers listed in the official recall notice. The affected units have specific serial numbers starting with 'SUT' followed by numbers and 'HA'.
Look for serial numbers starting with 'SUT' followed by numbers and 'HA' on the device.
The F2-01 Frame patient monitors with arrhythmia detection or alarms are being recalled due to a potential interruption in data communication between E-modules and patient monitors if the frame has not been powered down within the last 120 days.
Check the serial number on your device. If it matches the list of affected serial numbers provided in the recall notice, you should check the official recall website for further instructions.
The recall is for potential data communication issues, not a direct risk of injury. The hazard is low risk as it does not cause immediate harm but could affect monitoring accuracy.
We’ve drafted a message you can send GE Medical Systems China to request your refund or repair — edit it as you like.
Subject: Recall Z-2656-2023 — GE Medical Systems China GE Medical Systems China Hello, I own a GE Medical Systems China that is covered by recall Z-2656-2023 from GE Medical Systems China. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
