Z-0773-2014Class II

Imagecast PACS is an image management system intended to be used by trained professionals, including but not...

Name: Z-0773-2014 Imagecast PACS is an image management system intended to be used by trained professionals, including but not...
Creator: Ge Healthcare It
Published: 2011-03-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-03-04 / Terminated / root cause: software

FDA source

Ge Healthcare It began a recall of Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical... on 2011-03-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0773-2014
Classification: Class II
Status: Terminated
Initiated: 2011-03-04
Posted: 2014-01-15
Terminated: 2016-05-16
Recalling firm: GE Healthcare
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.
Product code: LLZ System, Image Processing, Radiological
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
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: Imagecast PACS versions prior to 3.6.51.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0773-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0773-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-15

Product code LLZ

K052618Class IIImagecast PacsIdx Systems Corp. / cleared 2005-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)