Revolution Apex…

Date

Nov. 4, 2020

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

Terminated

Filed by

GE Healthcare, LLC

Product

Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Reason

There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, NC, NE, NJ, PA, TX, VA, WA, and WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Japan, Kuwait, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Quantity

64 devices

Codes and lots

Model 5995000-5; Lot/Serial Numbers as below: REVVX1800093CN REVVX1700044CN REVVX1900040CN REVVX2000001CN REV2A1900002CN REV2A2000014CN REVVX2000031CN REV2A2000013CN REVVX1600023CN REVVX1800015CN REVVX1900092CN REV2A2000006CN REVVX1900003CN REV2A2000003CN REV2A2000015CN REV2A1900003CN REVVX1800061CN REV2A2000007CN REVVX1700078CN REVVX1900071CN REVVX1900006CN REVVX1900003CN REVVX1800124CN REVVX1800030CN 441066CN8 00000436942CN7 REV2A2000010CN 00000442968CN4 REVVX1900049CN 00000439505CN9 REVVX1700064CN 00000440315CN0 REV2A2000017CN DUMFMI25490001 REV2A2000001CN 00000442412CN3 REV2A2000002CN REVVX1700054CN REVVX1800100CN REV2A2000012CN REVVX1800040CN REVVX1600046CN REV2A2000016CN REGGL2000003YC REVVX1900013CN REVVX1600030CN REV2A1900001CN REVVX1700117CN REVVX1800083CN REVVX1700106CN 00000440441CN4 REV2A2000018CN REV2A1900005CN REV2A2000009CN 00000438438CN4 REVVX1900102CN REV2A2000011CN REV2A2000004CN DUMFMI25490005 4 included units with lot/serials not available.

Recall started

Sept. 21, 2020

Device type

System, X-Ray, Tomography, Computed

Root cause (FDA)

Device Design

What the company told customers

The recall strategy outlined below addresses the depth of the recall and recall notification (customer letter) effectiveness check. This issue will be resolved by sending an Urgent Medical Device Correction letter (attached) to customers with potentially affected systems. This letter will inform the customer of the issue and provide safety instructions for continued use. GE Healthcare will inspect potentially affected systems and correct, if needed. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the inspection and correction, if needed, of potentially affected systems. Records will be retained per our processes and procedures.

Recall number

Z-0306-2021

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

Source: FDA · Medical device enforcement report, recall number Z-0306-2021. The agency record governs; check it and the company before acting.