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U.S. Department of Health and Human Services

Class 2 Device Recall Imagecast PACS 3.5 and 3.6

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  Class 2 Device Recall Imagecast PACS 3.5 and 3.6 see related information
Date Initiated by Firm February 18, 2013
Create Date July 28, 2016
Recall Status1 Terminated 3 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.
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 2
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 and Original Applicant = IDX SYSTEMS CORP.
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