Ge Medical Systems China Co., Ltd.
Ge Medical Systems China Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2017, with 27 FDA device recalls on record.
Name variants for Ge Medical Systems China Co., Ltd.
as filed with FDA- Ge Medical Systems China Co., Ltd.
- Ge Medical Systems (China) Co., Ltd.
Top product codes for Ge Medical Systems China Co., Ltd.
FDA recalls by Ge Medical Systems China Co., Ltd.
10 most recent of 27- Z-2306-2026 — MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
- Z-0915-2026 — GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
- Z-0913-2026 — GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543
- Z-0914-2026 — GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002
- Z-2030-2025 — GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system
- Z-2029-2025 — GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
- Z-1636-2025 — GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002
- Z-1630-2025 — GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012
- Z-1629-2025 — GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002
- Z-1626-2025 — GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ge Medical Systems China Co., Ltd.
- K171580 — Monitor B125, Monitor B105
- K151063 — Monitor B40
- K142288 — MAC 800 Resting ECG Analysis System
- K133576 — MONITOR B40
- K130584 — MONITOR B40
- K122253 — PROCARE MONITOR B20
- K123238 — ACHILLES
- K120598 — PROCARE MONITOR B40
- K103633 — ACHILLES
- K102256 — GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND
- K102113 — GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND
- K091374 — GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
- K091164 — GE VENUE 40, MODEL 5324338
Data sourced from openFDA. This site is unofficial and independent of the FDA.