GE Centricity Universal Viewer Zero Footprint Client

Date

Dec. 8, 2021

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

GE Centricity Universal Viewer Zero Footprint Client

Reason

There is a potential to display incomplete patient imaging study.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, and WV. The countries of Argentina, Aruba, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Panama, Qatar, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Quantity

638 devices

Codes and lots

Versions 6.0 SP9, SP9.0.1, SP9.0.1.1, SP9.0.1.2, SP9.0.1.3, SP9.0.1.4, SP9.0.1.5, SP10, SP10.1, SP10.2, SP10.2.1, SP10.2.1.1, SP10.2.2, SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988; UDI 00840682102988.

Recall started

Oct. 15, 2021

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

The firm issued medical device correction letters dated 10/15/2021 on the same date via traceable means. The letter described the safety issue and actions to be taken. The letter informed the consignee they can continue to use the device by following the instructions provided in the letter until a GE Service Representative can restart their ZFP system.

Recall number

Z-0329-2022

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

Source: FDA · Medical device enforcement report, recall number Z-0329-2022. The agency record governs; check it and the company before acting.