—#176022

Product

Proteus XR/a (SlOK : K993090)

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K993090
Affected lot / code info: console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)

Why it was recalled

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide - US Nationwide

Timeline

Recall initiated: 2019-08-09
Posted by FDA: 2019-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.