The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- GE Carestation 600 series anesthesia systems
- Model numbers 620/650/650c, A1
- Serial numbers: 1012-9620-000, 1012-9620-002, 1012-9650-000, 1012-9650-002, 1012-9655-000, 1012-9655-002
- Manufacturing Dates: August 2018 to July 2019
- Distribution Dates: August 2018 to July 2019
- Devices Recalled in the U.S.: 3,599
- Date Initiated by Firm: November 25, 2019
The GE Healthcare Carestation 620/650/650c A1 anesthesia systems are used to provide general inhalation anesthesia and breathing support (mechanical ventilation) to pediatric and adult patients. The anesthesia systems are used in patient environments, such as hospitals, surgical centers, or clinics.
Reason for Recall
GE Healthcare is recalling the Carestation 620/650/650c A1 anesthesia systems because there is a potential for a loose cable connection inside the system which may cause the mechanical ventilation to stop working. If this occurs, the system will emit a high priority audio and visual alarm to alert the health care provider. Loss of mechanical ventilation could lead to low (hypoxia) blood oxygen levels in the patient if the health care provider does not ventilate the patient manually or with an alternate system.
The use of the affected product may cause the patient to have low blood oxygen levels, which could result in tissue or organ damage, or death.
There were no reported injuries or deaths.
Who May be Affected
- Health care providers using the GE Healthcare Carestation 620/650/650c A1 anesthesia systems
- Patients receiving breathing support with the GE Healthcare Carestation 620/650/650c A1 anesthesia systems
What to Do
On November 25, 2019, GE Healthcare sent a letter to customers informing them of the affected models and provided the following instructions:
- Continue using the system. A GE Healthcare representative will contact customers to inspect and correct the affected systems.
- If health care providers observe the message "Ventilate manually" and hear the audible alarm during use of the system, they should switch from mechanical ventilation to manual ventilation or switch to another anesthesia system.
- Hospitals should perform planned maintenance on the systems at least every 12 months. This will confirm that the cable is connected properly.
Customers who have questions regarding this notification should contact GE Healthcare Customer Service at 1-800-437-1171, 24 hours per day and 7 days per week
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.