Class 2 Device Recall Imagecast PACS 3.5 and 3.6

• Date Initiated by Firm: February 18, 2013
• Create Date: July 28, 2016
• Recall Status: Terminated on December 13, 2017
• Recall Number: Z-2300-2016
• Recall Event ID: 64758
• 510(K)Number: K052618
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: 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 interpretation. 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.
• Code Information: Imagecast PACS 3.5.69, 3.5.86, 3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.
• FEI Number: 3004526608
• Recalling Firm/ Manufacturer: Ge Healthcare It; 540 W Northwest Hwy; Barrington IL 60010-3051
• For Additional Information Contact: Jeme Wallace; 847-277-4468
• Manufacturer Reason for Recall: A software defect was discovered that causes images to be out of context with clinical information.
• FDA Determined Cause: Software design
• Action: 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. The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI #85204. For further questions, please call ( 847) 277-4468.
• Quantity in Commerce: 13
• Distribution: US Nationwide Distribution.
• 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