Reported Jan 22, 2014 · Terminated
Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to…
Ge Healthcare It
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ge Healthcare It · 540 W Northwest Hwy · Barrington, IL · 60010-3051
Is this the product you have?
- 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.
- Lot codes and dates
- Imagecast PACS versions prior to 3.6.51.01
- Amount recalled
- 43 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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