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

FDA device recall Z-3214-2024 · posted 2024-09-24 · Open, Classified

Recall details

Recalling firm

GE Healthcare

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.

Action taken

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/05/2024 by letter delivered via traceable means. The notice explained the issue, potential risk to the patient, and requested the following: "You can continue to use your device if it has not reached the maximum number of Ckeys. In order to determine the remaining number of available Ckeys: " If GE HealthCare is remotely monitoring your Centricity PACS system as part of an existing service agreement, the number of available Ckeys is assessed routinely. If your device is close to maximum capacity, the GE HealthCare support team will contact you to discuss next steps. " If GE HealthCare is not remotely monitoring your system, please contact the GE HealthCare support team who will help you check your Ckey status. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions above." "GE HealthCare will provide an updated manual with CKey monitoring instructions at no cost to you. A GE HealthCare representative will contact you with further information." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Device Design

Status

Open, Classified

Product code

LLZ

Quantity affected

2138 units

Distribution

Worldwide distribution.

Date initiated

2024-08-05

Date posted

2024-09-24

Location

Chicago, IL

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