Z-2449-2019Class II

Proteus XR/a (SlOK : K993090)

Name: Z-2449-2019 Proteus XR/a (SlOK : K993090)
Creator: GE Healthcare, LLC
Published: 2019-08-09
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-08-09 / Open, Classified / root cause: design

FDA source

GE Healthcare, LLC began a recall of Proteus XR/a (SlOK : K993090) on 2019-08-09. FDA classified it as Class II and gives the reason as "Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2449-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-08-09
Posted: 2019-09-20
Recalling firm: GE Healthcare
Product: Proteus XR/a (SlOK : K993090)
Product code: KPR System, X-Ray, Stationary
Reason for recall: Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 647 US; 167 OUS
Distribution: Worldwide - US Nationwide
Product codes and lots: console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2449-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2449-2019	Class II	Ongoing	FDA Mandated	2019-10-02	2019-09-20

Product code KPR

K993090Class IISilhouette FcGe Medical Systems, Inc. / cleared 1999-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)