Recall Z-3214-2024— GE Healthcare

Name: FDA recall Z-3214-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-05

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, initiated 2024-08-05. It names 2 FDA 510(k) clearances: K110875, K043415. Product: GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.. Reason: GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study..

Recalling firm: GE Healthcare
Classification: Class II
Status: Ongoing
Initiated: 2024-08-05
Firm location: Chicago, IL, United States

510(k) clearances named in this recall

2 on FDA's record

K110875 — CENTRICITY PACSGE Healthcare·cleared 2011-05-05
K043415 — CENTRICITY PACS SYSTEMGe Medical Systems Information Technologies·cleared 2005-01-21

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

GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

Reason for recall

GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.

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