Recall – Intermittent image artifacts on CT Diagnostic Imaging System

Company: Shanghai United Imaging Healthcare Co., Ltd.
Date of Enforcement Report: 8/19/2020
Class II

PRODUCT

uEXPLORER PET/CT Diagnostic Imaging System – Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Recall Number: Z-2799-2020

REASON

Issues were identified with the PET/CT diagnostic imaging systems including: a potential intermittent issue leading to image artifacts; potential intermittent scout scanning interruption; a problem with one of the service functions which may cause false marking of a bad channel resulting in ring artifacts; and the possibility of unevenness of the metal edge which overlaps the mylar strip in the gantry which may create a sharp edge. These issues may require re-scanning of the patient resulting in additional radiation exposure, and possible abrasion to the patient’s arm from a sharp metal edge.

RECALLING FIRM/MANUFACTURER

Shanghai United Imaging Healthcare Co., Ltd. on 7/16/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1 unit distributed to Texas

DISTRIBUTION

U.S. Nationwide

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.