Terminated

GE Centricity Universal Viewer Zero Footprint Client

FDA Recall Z-0329-2022 · Posted None

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeLLZ

Date Initiated2021-10-15

Date Terminated2026-08-17

Product Quantity638 devices

Reason for Recall

There is a potential to display incomplete patient imaging study.

Firm Action

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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131977CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENTGE Healthcare · 2013-09-17

Official Source

View FDA Recall →

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