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Open, Classified

Proteus XR/a (SlOK : K993090)

FDA Recall Z-2449-2019 · Posted 2019-09-20

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeKPR
Date Initiated2019-08-09
Product Quantity647 US; 167 OUS

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide - US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993090SILHOUETTE FCGe Medical Systems, Inc. · 1999-10-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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