510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-2180-2008

Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all...

AGFA Healthcare Corp. / initiated 2008-06-04 / Terminated / root cause: software
FDA source (opens on fda.gov)

AGFA Corp. began a recall of Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions. The Impax Systems are Picture Archiving... on . The reason FDA records is "The IMPAX client failed to "refresh" the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the "active" study". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2180-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
AGFA Healthcare Corp.
Product
Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions. The Impax Systems are Picture Archiving and Communications system (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images.
Product code
LLZ System, Image Processing, Radiological
Reason for recall
The IMPAX client failed to "refresh" the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the "active" study.
Root cause tag
software
FDA root cause
Software design
Action
An "Urgent Safety Notice" letter was sent to all the sites using potentially affected units on/about June 4, 2008. Dealers were notified via letter on June 9, 2008. The letter requests that all users be reminded that Agfa recommends the system is configured so that demographic information is not removed from the image viewing area. They will be provided with the appropriate Service Update, based on the current version of IMPAX Client 6.x in use at their site. They were advised to distribute the information within their facility to all those who need to be aware of it. A FAX Back form was requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. Contact AGFA at 1-877-777-2432, prompts 1, 2, 1.
Quantity in commerce
371 units
Distribution
U.S., Canada, Europe, Asia Pacific and Latin America.
Product codes and lots
Catalog Numbers for Impax 6.x Client Software: Radiologist Viewer - R6.0 Concurrent User, Package Code: 60+000250353, Product Code: L8DTC; Breast Imaging Radiologist Viewer - R6.0 Concurrent User, Package Code: 60+00025055, Product Code: L8DGM; Orthopeadic Viewer - R6 Concurrent User, Package Code: 60+00025056, Product Code: L8DEH, L4NVL; Radiologist w/QC Viewer - Concurrent User: Product Code: EW43C; Breast Imaging Radiologist w/QC Viewer - Concurrent User, Product Code: EW44E; Enterprise Viewer - Concurrent License, Product Code: L8DP3; Impax¿ 6 Orthopeadic Center Client Site License, Product Code: EW21Y; Impax¿ 6 Site License (includes client site license above - L8FEQ), Package Code: 60+00025123, and Product Code: L8FEQ.