# FDA recall Z-0913-2026

> **GE Medical Systems China Co., Ltd.** · Class I · device recall initiated 2025-11-14.

## Product

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 1012-9655-200 001

## Reason for recall

Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.    Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur.   Following the reboot, the system will not return to the previous ventilation settings.

## Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Moldova, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Vietnam.

## Key facts

- **Recall number:** Z-0913-2026
- **Recalling firm:** GE Medical Systems China Co., Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-14
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wuxi, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0913-2026

## Citation

> AI Analytics. FDA recall Z-0913-2026. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-0913-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*