Proteus XR/a (SlOK : K993090)
This recall is currently active, issued September 20, 2019. It was issued by Ge Healthcare, Llc.
- Company
- Ge Healthcare, Llc
- Recall Initiated
- August 9, 2019
- Posted
- September 20, 2019
- Recall Number
- Z-2449-2019
- Quantity
- 647 US; 167 OUS
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
Distribution
Worldwide - US Nationwide
Lot / Code Info
console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)
Root Cause
Device Design
Action Taken
GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare representative will contact you to arrange for the correction . If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1- 800-437-1171or your local Service Representative.