Reported Oct 11, 2023 · Ongoing
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
GE Medical Systems China Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems China Co., Ltd. · National Hi-Tech · Wuxi, N/A · N/A
Is this the product you have?
- F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
- Lot codes and dates
- UDI/DI 010019527852408921
- Serial Numbers
1,638 of 1,638 codes
SUT23230108HASUT23230111HASUT23240034HASUT23240035HASUT23230106HASUT23230107HASUT23230109HASUT23230110HASUT23230112HASUT23230113HASUT23230114HASUT23240001HASUT23240002HASUT23240003HASUT23240004HASUT23240005HASUT23240006HASUT23240007HASUT23240008HASUT23240009HASUT23240010HASUT23240011HASUT23240012HASUT23240013HASUT23240014HASUT23240015HASUT23240016HASUT23240018HASUT23240019HASUT23240020HASUT23240021HASUT23240022HASUT23240023HASUT23240024HASUT23240025HASUT23240026HASUT23240027HASUT23240028HASUT23240029HASUT23240030HASUT23240032HASUT23230100HASUT23230101HASUT23230102HASUT23240017HASUT23240036HASUT23240037HASUT23240038HASUT23240039HASUT23240040HASUT23240042HASUT23240043HASUT23240044HASUT23240048HASUT23240049HASUT23240050HASUT23240051HASUT23240052HASUT23240053HASUT23240054HA
- Amount recalled
- 1638 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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