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U.S. Department of Health and Human Services

Class 2 Device Recall RM, RMAT

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 Class 2 Recall
RM, RMAT
see related information
Date Posted February 25, 2011
Recall Status1 Terminated on October 13, 2011
Recall Number Z-1435-2011
Recall Event ID 57820
Premarket Notification
510(K) Number
K050228 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows 2000/2003/XP operating systems. Image data storage/display utilizes DICO< (Digital Imaging and Communications in Medicine) data primarily from independent medical devices.
Code Information Software Versions: RM 2.03, 2.04 & 2.06
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Jeffery A. Jedlicka
864-421-1815
Manufacturer Reason
for Recall
User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, Agfa Healthcare, sent individual letters dating from April 15, 2009 to August 26, 2009, to the customers. The letters described the product, problem and actions to be taken. Agfa provided the affected customer with a complete list of their impacted patients and the measurements. Agfa also scheduled unit corrections with their customers and received acknowledgement of the letters at the time of scheduling the unit corrections. Service Bulletin DIS026.09E was issued January 2009 to inform users that Agfa will no longer allow customers to request unit changes for measurements that have formulas. Note: Technical Support ran diagnostic scripts for each customer and documented in GSC cases for each consignee/customer. If you have any questions, contact Agfa Healthcare at (949) 830-4959.
Quantity in Commerce 6 devices
Distribution Nationwide distribution: USA including states of: IL, MT, NY, OR and SC.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
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