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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX Cardiovascular Polling Procedure version 1.00.09

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  Class 2 Device Recall IMPAX Cardiovascular Polling Procedure version 1.00.09 see related information
Date Initiated by Firm December 24, 2008
Date Posted February 03, 2009
Recall Status1 Terminated 3 on April 01, 2010
Recall Number Z-0945-2009
Recall Event ID 50755
510(K)Number K022292  K050228  
Product Classification Image Processing Radiological System - Product Code LLZ
Product IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000.

IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demographic and merge/split operations performed on the IMPAX database utilizing the IMPAX Service Tool are captured and applied to the IMPAX CV database, in order to keep patient updates from the IMPAX database synchronized with the IMPAX CV database.
Code Information Serial number: KQRCPF9, Equipment number: 15013696, ; Serial number: BQWBZ81, Equipment number: 10281800; Serial number: FB5C561, Equipment number: 10262174; Serial number: USE708NBP3, Equipment number: 15003839; and Serial number: GN6Z1E1, Equipment number: 15009724.
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D
864-421-1815
Manufacturer Reason
for Recall		 Polling procedure may fail when multiple merge/split is carried out.
FDA Determined
Cause 2		 Software design
Action All sites potentially affected by this product were notified of the issue directly via telephone. Each site was directed to observe a ten minute polling window as an interim mitigation until the normal mitigation by software Service Update is performed at the site by Agfa Support. An Urgent Safety Notice was sent via FED-EX on/about 12/24/2008 to all sites. The letter describes the potential issue and both interim and formal mitigation. Acknowledgment, via FAX-Back, that the information was received and understood was requested from the sites.
Quantity in Commerce 5 units
Distribution Nationwide Distribution --- including states of FL, IL, OR, SC, and SD.
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 = AGFA CORP.
510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
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