GE Medical Systems China Co., Ltd.
FDA Regulatory Profile
GE Medical Systems China Co., Ltd. appears in FDA public data with 27 recalls — including 18 Class I (most serious) —, 12 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2306-2026, Class II) was initiated on April 21, 2026. Its most recent 510(k) clearance was granted on December 15, 2015.
Summary
- Total Recalls
- 27 (18 Class I)
- 510(k) Clearances
- 12
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2306-2026 | Class II | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. | April 21, 2026 |
| Z-0914-2026 | Class I | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, | November 14, 2025 |
| Z-0915-2026 | Class I | GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU | November 14, 2025 |
| Z-0913-2026 | Class I | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, | November 14, 2025 |
| Z-2029-2025 | Class II | GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound syst | May 16, 2025 |
| Z-2030-2025 | Class II | GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: | May 16, 2025 |
| Z-1635-2025 | Class I | GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. | March 21, 2025 |
| Z-1634-2025 | Class I | GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system. | March 21, 2025 |
| Z-1638-2025 | Class I | GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system. | March 21, 2025 |
| Z-1624-2025 | Class I | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems | March 21, 2025 |
| Z-1636-2025 | Class I | GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system. | March 21, 2025 |
| Z-1625-2025 | Class I | GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system. | March 21, 2025 |
| Z-1633-2025 | Class I | GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system. | March 21, 2025 |
| Z-1630-2025 | Class I | GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system. | March 21, 2025 |
| Z-1631-2025 | Class I | GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system. | March 21, 2025 |
| Z-1629-2025 | Class I | GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system. | March 21, 2025 |
| Z-1626-2025 | Class I | GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system. | March 21, 2025 |
| Z-1628-2025 | Class I | GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. | March 21, 2025 |
| Z-1637-2025 | Class I | GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. | March 21, 2025 |
| Z-1632-2025 | Class I | GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. | March 21, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K151063 | Monitor B40 | December 15, 2015 |
| K142288 | MAC 800 Resting ECG Analysis System | December 3, 2014 |
| K133576 | MONITOR B40 | February 21, 2014 |
| K130584 | MONITOR B40 | June 26, 2013 |
| K122253 | PROCARE MONITOR B20 | March 22, 2013 |
| K123238 | ACHILLES | February 25, 2013 |
| K120598 | PROCARE MONITOR B40 | July 19, 2012 |
| K103633 | ACHILLES | May 11, 2011 |
| K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND | October 5, 2010 |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | August 12, 2010 |
| K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | May 26, 2009 |
| K091164 | GE VENUE 40, MODEL 5324338 | May 5, 2009 |