Imagecast PACS with Centricity RIS-IC versions prior to 10 — Class II medical device recall Z-2300-2016
Terminated recall by Ge Healthcare It, reported 2016-08-03, distributed nationwide. A software defect was discovered that causes images to be out of context with clinical information.
| Recall number | Z-2300-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | Ge Healthcare It, Barrington, IL, United States |
| Recall initiated | 2013-02-18 |
| Classified | 2016-07-28 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2017-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 13 |
| Reason classes | software |
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 for recall
A software defect was discovered that causes images to be out of context with clinical information.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2300-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.