Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2656-2023 — F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

U.S. FDA — Device Enforcement · China · 2023-09-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2656-2023
Date of alert
2023-09-08
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
GE Medical Systems China Co., Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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