Class I Recall of GE Healthcare's CareScape R860 Inspiratory Safety Guard

Published: 12/12/2018

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

GE Healthcare is recalling the CareScape R860 Inspiratory Safety Guard due to the risk of the device disconnecting from the patient’s breathing circuit. As the result of a manufacturing defect, the safety guard’s outlet connector may have incorrect dimensions, which could result in the device not having a secure fit with the breathing circuit. This may result in the patient not receiving breathing support. The U.S. Food and Drug Administration has classified this as a Class I Recall.

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