Imagecast PACS is an image management system intended recall
Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical…
Why was Imagecast PACS is an image management system intended 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Imagecast PACS versions prior to 3.6.51.01
- Product
- Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical…
- Recalling firm
- Ge Healthcare It
- Quantity
- 43 units
- Distribution
- Nationwide Distribution: US including states of: AL, AZ, CT, FL, GA, IA, IN, LA, MA, MI, MN, MO, NC, NH, NJ, NY, OH, PA, TX, VA, WI, WV + District of Columbia.
- Recall date
- January 22, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)