FDA Device recall Z-2656-2023
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) by Ge Medical Systems China, citing 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 Fra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2656-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-08 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Medical Systems China |
| Distribution | US |
Product
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Reason
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.
Identifiers
| code_info | UDI/DI 010019527852408921, Serial Numbers: SUT23230108HA, SUT23230111HA, SUT23240034HA, SUT23240035HA, SUT23230106HA,…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, SUT23240058 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2656-2023%22
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