FDA Medical Device Recalls (openFDA)
Ge Healthcare It: 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.
- Recall number
- Z-0773-2014
- Recalling firm
- Ge Healthcare It
- 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.
- Status
- Terminated
- Initiated
- 2011-03-04
- Posted
- 2014-01-15
- Terminated
- 2016-05-16
- Reason
- 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
- Root cause
- Software design
- Action
- 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.
- 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.
- Lot, serial or model codes
- Imagecast PACS versions prior to 3.6.51.01
- 510(k) numbers
- ["K052618"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3004526608
- Firm city
- Barrington
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28