Imagecast PACS is an image management system intended to be used by… — Class II medical device recall Z-0773-2014
Terminated recall by Ge Healthcare It, reported 2014-01-22, distributed nationwide. In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounte
| Recall number | Z-0773-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ge Healthcare It, Barrington, IL, United States |
| Recall initiated | 2011-03-04 |
| Classified | 2014-01-15 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2016-05-16 |
| Distributed | Nationwide (US) |
| Quantity | 43 units |
Product
Imagecast PACS 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 and interpretations. Mammongraphic 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
In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. These versions of Imagecast PACS look for values to be present in the following tags to calculate a measurement from pixels to millimeters (mm): (0020,0030) Pixel Spacing and, (0018,1164) Imager Pixel Spacing. Because the estimated magnification factor is not used, distance meas
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-0773-2014. 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.