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FDA puts high-risk label on GE Healthcare anesthesia systems recall

Dive Brief:

  • FDA on Friday flagged a recall GE Healthcare initiated in late November of nearly 3,600 anesthesia systems with a potential loose cable connection that could lead to a loss in mechanical ventilation.
  • The agency classified the recall as Class I, meaning use of the affected devices may result in serious injuries or death. In the case of the Carestation 600 series devices, a halt in mechanical ventilation cause a patient to have low blood oxygen, which could lead to tissue or organ damage or death. FDA said Friday there had been no reported injuries or deaths.
  • So far in 2020 the agency has classified 19 recalls as Class I, according to its medical devices recall database.

Dive Insight:

The systems are used for general inhalation anesthesia and breathing support in both pediatric and adult patients at hospitals, surgical centers or clinics, according to FDA’s notice.

FDA highlighted GE’s guidance from a Nov. 25 letter to customers advising continued use of the systems. GE also said that if healthcare providers see a “Ventilate manually” message and hear an alarm while using the system, they should switch from mechanical to manual ventilation or switch to a different anesthesia system. GE also reportedly advised hospitals to carry out planned system maintenance at least once a year to ensure the cable is connected correctly.

The devices affected are GE Carestation 600 series anesthesia systems manufactured and distributed between August 2018 and July 2019, with model numbers 620/650/650c or A1, and serial numbers 1012-9620-000, 1012-9620-002, 1012-9650-000, 1012-9650-002, 1012-9655-000, or 1012-9655-002.

The majority of FDA’s Class I recalls so far this year are in regard to GE Healthcare products, particularly in relation to its Carescape Respiratory Modules. Affected devices are used with patient monitors and ventilators to assess breathing characteristics and measure respiratory gases like oxygen and carbon dioxide, but may display incorrect values.

Other Class I recalls relate to certain humidification systems from Teleflex, insulin pump systems from Medtronic, ventilators from ResMed and laryngoscopes from Ambu.


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