FDA recalls about 3,600 GE Healthcare anesthesia systems — 4 insights

The FDA on Feb. 7 issued a class 1 recall for 3,599 GE Carestation 600 series anesthesia systems because of a flaw that can cause the mechanical ventilation system to stop working.

What you should know:

1. The devices were manufactured and distributed between August 2018 and July 2019. GE Healthcare initiated the recall Nov. 25, 2019.

2. The flaw stems from a loose cable connection. If the connection became loose, the system would emit a loud audio and visual alarm to alert the provider. The flaw will cause the patient to have low blood oxygen levels if the anesthesiologist does not take action.

3. There have been no reported injuries or deaths.

4. GE Healthcare sent out representatives to correct the affected systems. GE also recommends that hospitals perform maintenance on the system every 12 months to ensure the cable is connected properly.

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