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# GE Healthcare Class 1 Recall of Ventilator Safety Guard
- URL: https://www.fdaweb.com/ge-healthcare-class-1-recall-of-ventilator-safety-guard/
- Published: 2018-12-12T12:00:00.000Z
- Updated: 2026-09-15T00:50:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143029

FDA has classified as Class 1 a GE Healthcare recall of its CareScape R860 Inspiratory Safety Guard, a breathing accessory designed for use with the Carescape R860 Ventilator. The ventilator provides mechanical ventilation and breathing support to infants, children, and adult patients, and the safety guard is designed for use within or during transport between medical facilities. The recall was undertaken due to the risk of the device disconnecting from the patient’s breathing circuit, according to a [recall notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm628292.htm?utm%5Fcampaign=FDA%20MedWatch%20Recall%20Notice%20-%20CareScape%20R860%20Inspiratory%20Safety%20Guard&utm%5Fmedium=email&utm%5Fsource=Eloqua&elqTrackId=a0637f40e3b2482f91d8db7f781201dc&elq=efa989633fad4815b270eefec3123e1b&elqaid=6265&elqat=1&elqCampaignId=5099). 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, it says.