If the customer elects to not upgrade the software, instructions were provided for a new system calibration procedure. The software upgrade can be requested from GE Support via the eService portal or by telephone at 1-80. The letters advised customers to upgrade their PACS software version to Imagecast 3.6. Important Product Information Letters dated Mawere sent to all customers that received the defective software. 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.īecause the estimated magnification factor is not used, distance meas In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. Imagecast PACS versions prior to 3.6.51.01 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. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image and interpretations. Data and images are acquired through DICOM compliant imaging devices and modalities. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = LLZ and Original Applicant = IDX SYSTEMS CORP.System, image processing, radiological - Product Code LLZ 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. The modified software will be released and installed in user sites through GE Healthcare FMI #85204.įor further questions, please call ( 847) 277-4468.ġ A record in this database is created when a firm initiates a correction or removal action. The software has been modified to correct these defects. GE sent an "Urgent Medical Device Correction" letter to all affected customers on April 2, 2013.The letter identified the product the problem and the action customers need to take. RIS-IC 10.6 versions prior to update Package 18.Ī software defect was discovered that causes images to be out of context with clinical information. Mammographic images 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. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 System, image processing, radiological - Product Code LLZ Class 2 Device Recall Imagecast PACS 3.5 and 3.6
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