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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ 510(K)s with Product Code = LLZ
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