Recall Z-1500-2023— GE Healthcare

Name: FDA recall Z-1500-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-28

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, initiated 2023-03-28. It names one FDA 510(k) clearance: K123174. Product: Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System. Reason: GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information..

Recalling firm: GE Healthcare
Classification: Class II
Status: Ongoing
Initiated: 2023-03-28
Firm location: Chicago, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K123174 — CENTRICITY PACS-IW WITH UNIVERSAL VIEWERGE Healthcare·cleared 2012-11-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System

Reason for recall

GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

Data sourced from openFDA. This site is unofficial and independent of the FDA.