GE Medical Systems China Co., Ltd.
Complete recall history across all FDA and CPSC categories — 26 total recalls
GE Medical Systems China Co., Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (26)
FDA medical device enforcement actions by GE Medical Systems China Co., Ltd.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 14, 2025 | GE Healthcare Carestation anesthesia system Power Management Board (PMB) Fiel... | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Sy... | Class I |
| Nov 14, 2025 | GE Healthcare Carestation anesthesia system, product number and REF numbers: ... | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Sy... | Class I |
| Nov 14, 2025 | GE Healthcare Carestation anesthesia system, product number and REF numbers: ... | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Sy... | Class I |
| May 16, 2025 | GE Healthcare Versana Ultrasound Systems, sold under the following names and ... | GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurem... | Class II |
| May 16, 2025 | GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, dia... | GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurem... | Class II |
| Mar 21, 2025 | GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Mar 21, 2025 | GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/... | Class I |
| Sep 8, 2023 | F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) | There is a potential interruption of data communication between E-modules ins... | Class II |
| Jul 24, 2018 | GE 9100c NXT anesthesia systems | On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a p... | Class II |
| Jul 24, 2018 | GE Carestation 30 anesthesia systems | On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a p... | Class II |
| Jul 24, 2018 | GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems | On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a p... | Class II |
| Oct 11, 2017 | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 | Possible incomplete seal between the CO2 absorber and the breathing circuit C... | Class II |
| Oct 11, 2017 | Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 | Possible incomplete seal between the CO2 absorber and the breathing circuit C... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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