Flow-c (anesthesia machine)

2022: Anesthesia device recalls

In July 2022, Getinge began recalling the Flow-c and Flow-e anaesthetic systems due to the risk of death or serious injury to patients. The service campaign is started after receiving reports of cracked or broken on/off switches on the suction unit of the device.

The Flow-c and Flow-e anaesthetic systems are used to provide inhalation anaesthesia and control the ventilation process in patients who cannot breathe. Designed for patients from newborns to adults, these machines are also used for patients who are unable to breathe on their own.

Anesthesia devices Flow-c and Flow-e are being recalled

According to the notice, FDA if the device switch breaks, the suction device will not be able to remove fluids such as sputum, blood or stomach contents from the patient's mouth or respiratory tract. In addition to the potential delay of procedures, broken suction systems can cause fluids to block patients' breathing, which can lead to suffocation, the inability to supply oxygen to the blood, pulmonary infection, traumatic brain injury caused by lack of oxygen, and death, writes the FDA.

The recall affects 64 devices in the United States. Getinge has received 21 complaints over the issue, but has not received a single report of patient injuries or deaths. The latest Class I recall is Getinge's fifth since September 2021, including feedback relating to its Atrium Medical and Datascope subsidiaries.

Getinge, based in Gothenburg, Sweden, sent a recall letter to customers on May 2, 2022, recommending that they immediately check for damaged devices, the FDA said. The company asked users of the recalled devices to check the performance of the suction device and, if a cracked or broken switch is found, replace the anesthetic devices.

The recall affects devices released from June 2, 2020 to February 15, 2022.^[1]

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