Recall archive
7 recalls · page 1 of 1
Reported Jun 10, 2026
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems China Co., Ltd.
Matched: Brand · Product · Product details — Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being…
FDA (openFDA device enforcement)
Reported Dec 24, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222;…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Medical Systems China Co., Ltd.
Matched: Brand · Product · Product details · Reason for recall — Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems China Co., Ltd.
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Medical Systems China Co., Ltd.
Matched: Brand · Product · Product details · Reason for recall — Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV)…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems China Co., Ltd.
Matched: Brand — There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000…
FDA (openFDA device enforcement)
Reported Sep 5, 2018
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems China Co., Ltd.
Matched: Brand · Product · Product details · Reason for recall — On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2018
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems China Co., Ltd.
Matched: Brand · Reason for recall — Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
1 more product in this recall
FDA (openFDA device enforcement)
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