Food, drugs, devices › GE Medical Systems China Co., Ltd.
Device recall: Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
FDA enforcement event 78469 is a device recall by GE Medical Systems China Co., Ltd. of Wuxi, initiated 11 Oct 2017 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. GE Medical Systems China Co., Ltd. has 7 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Medical Systems China Co., Ltd., Wuxi, China.
Reason for recall
"Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems."
Distribution
"Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV. Distributed…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0579-2018 | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 | 5,148 devices | Class II | Ongoing | 21 Feb 2018 |
| Z-0580-2018 | Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 | 5,148 devices | Class II | Ongoing | 21 Feb 2018 |
Context
Other enforcement events for GE Medical Systems China Co., Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Apr 2026 | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph | Device | Class II | 1 |
| 14 Nov 2025 | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Care | Device | Class I | 3 |
| 16 May 2025 | GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system | Device | Class II | 2 |
| 21 Mar 2025 | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems | Device | Class I | 15 |
| 8 Sep 2023 | F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) | Device | Class II | 1 |
| 24 Jul 2018 | GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems | Device | Class II | 3 |
All 7 events for GE Medical Systems China Co., Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV. Distributed…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.