Carestation 600 Series Anesthesia Systems by GE Healthcare- Class I Recall

A MedWatch Safety Alert was added to the FDA Medical Device Recalls webpage. 

TOPIC: Carestation 600 Series Anesthesia Systems by GE Healthcare: Class I Recall - Due to Loss of Mechanical Ventilation

AUDIENCE: Anesthesiology, Health Professional, Risk Manager

ISSUE: 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.

Serial numbers for Carestation 620/650/650c A1 that are being recalled: 

• 1012-9620-000
• 1012-9620-002
• 1012-9650-000
• 1012-9650-002
• 1012-9655-000
• 1012-9655-002

RECOMMENDATION:

•  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.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.