Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to
FDA device recall Z-0773-2014 · posted 2014-01-15 · Terminated
Recall details
- Recalling firm
- Ge Healthcare It
- 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
- Action taken
- Important Product Information Letters dated March 4, 2011 were sent to all customers that received the defective software. The letters advised customers to upgrade their PACS software version to Imagecast 3.6. The software upgrade can be requested from GE Support via the eService portal or by telephone at 1-800-437-1171. If the customer elects to not upgrade the software, instructions were provided for a new system calibration procedure.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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.
- Date initiated
- 2011-03-04
- Date posted
- 2014-01-15
- Date terminated
- 2016-05-16
- Location
- Barrington, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMAGECAST PACS (K052618) | Idx Systems Corp. | 2005-11-17 |