AGFA Corp. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
AGFA Corp.
Lot Codes / Batch Numbers
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.
Products Sold
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.
AGFA Corp. is recalling IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numb due to Polling procedure may fail when multiple merge/split is carried out.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Polling procedure may fail when multiple merge/split is carried out.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026