FDA recall Z-3214-2024

Product

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-08-05

Report date

2024-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3214-2024