GE Healthcare has recalled its CE Carestation 600 series anesthesia systems, model numbers 620/650/650c, A1. The reason for the recall is that there is a potential for a loose cable connection inside the system that 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 healthcare provider does not ventilate the patient manually or with an alternate system. 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 have been no reported deaths or injuries related to the use of this product.
The recall affects devices with serial numbers 1012-9620-000, 1012-9620-002, 1012-9650-000, 1012-9650-002, 1012-9655-000, 1012-9655-002, manufactured and distributed between August 2018 and July 2019. A total of 3,599 devices in the United States may be affected.
In late 2019, GE Healthcare sent a letter to customers who have affected models with the following instructions:
- Continue using the system. A GE Healthcare representative will contact customers to inspect and correct the affected models.
- If healthcare providers hear the alarm and observe the message “Ventilate manually” 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.
The FDA has identified this as a Class I recall, the most serious type, since use of the product could cause serious injuries or death. For additional information, see the FDA recall notice.