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U.S. Department of Health and Human Services

Class 2 Device Recall Imagecast PACS

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  Class 2 Device Recall Imagecast PACS see related information
Date Initiated by Firm March 04, 2011
Date Posted January 15, 2014
Recall Status1 Terminated 3 on May 16, 2016
Recall Number Z-0773-2014
Recall Event ID 64740
510(K)Number K052618  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information Imagecast PACS versions prior to 3.6.51.01
Recalling Firm/
Manufacturer		 Ge Healthcare It
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact GE Service Organization
800-437-1171
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = IDX SYSTEMS CORP.
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