Recall – Radiographic system not providing audible exposure indication

Company: GE Healthcare, LLC
Date of Enforcement Report: 10/2/2019
Class II

PRODUCT

Proteus XR/a (SlOK : K993090)

  • Recall Number: Z-2449-2019

REASON

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

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 8/9/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

647 US; 167 OUS

DISTRIBUTION

US Nationwide and International

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.