GE Medical Systems China Co., Ltd.: Carestation Anesthesia Systems Recalled for Ineffective VCV Mode Ventilation

What You Should Do

1. Identify if your anesthesia system is affected by checking the model and REF numbers located on the device label; affected models include Carestation 620, 650, 650c, 750, and 750c with REF numbers such as 1012-9620-000, 1012-9650-000, and 1012-9750-000.
2. Check your device's unique serial number against the extensive list of affected units (serial numbers begin with prefixes like SM62, SM72, SM82, SQS2, or SQT2) provided in the recall documentation.
3. If you are using an affected device, do not rely on the Volume Control Ventilation (VCV) mode as it may not provide effective patient ventilation.
4. Ensure that effective ventilation is provided by using Pressure Control Ventilation (PCV), Pressure Control Ventilation Volume Guarantee (PCV-VG) modes, or Manual ventilation protocols as these remain functional.
5. Contact your local GE HealthCare service representative or the manufacturer directly to receive further technical instructions and to schedule any required system inspections or updates.
6. Inform clinical staff and healthcare providers at your facility about this issue to ensure patient safety during procedures requiring anesthesia.
7. For additional questions regarding this recall, contact the FDA at 1-888-463-6332 or visit the official recall page at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products