Proteus XR/a (SlOK : K993090)

Date

Oct. 2, 2019

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

GE Healthcare, LLC

Product

Proteus XR/a (SlOK : K993090)

Reason

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

Distribution pattern

Worldwide - US Nationwide

Quantity

647 US; 167 OUS

Codes and lots

console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)

Recall started

Aug. 9, 2019

Device type

System, X-Ray, Stationary

Root cause (FDA)

Device Design

What the company told customers

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.

Recall number

Z-2449-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2449-2019. The agency record governs; check it and the company before acting.