FDA Device recall Z-2300-2016
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be…
- FDA Device
- Class II
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class II recall of Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be… by Ge Healthcare It, citing A software defect was discovered that causes images to be out of context with clinical information.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2300-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-18 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare It |
| Distribution | US |
Product
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.
Reason
A software defect was discovered that causes images to be out of context with clinical information.
Identifiers
| code_info | Imagecast PACS 3.5.69, 3.5.86, 3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2016-09-07 · Ge Healthcare It - GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic an…
FDA Device · Class II · 2016-08-24 · Ge Healthcare It - Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data
FDA Device · Class II · 2014-12-31 · Ge Healthcare It - The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities ass…
FDA Device · Class III · 2014-02-05 · Ge Healthcare It
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2300-2016%22
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