IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting.
FDA Recall Z-0212-2012 · Posted 2011-11-18
Advertisement
Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-06-06
Date Terminated2014-05-08
Product Quantity280
Reason for Recall
Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR).
Firm Action
The firm, AGFA HealthCare" sent an 'URGENT FIELD SAFETY NOTICE" dated May 27, 2011 via FED-EX by June 6, 2011 to all customers using the affected product. The letter describes the product, problem and actions to be taken. The customers were instructed to distribute this information within their facility to all those who need to be aware and to complete and return the attached FEEDBACK FORM via fax to 864-421-1668 or email to [email protected]. AGFA will provide software corrections to all affected sites and will contact the customers to schedule the analysis and provide any corrections if required.
If you have any questions about this matter, please contact your local Agfa HealthCare Service at 877-777-2432.
Root Cause
Pending
Distribution Pattern
Worldwide distribution: AK, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WV; and country of: Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement