IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascu

FDA device recall Z-0212-2012 · posted 2011-11-18 · Terminated

Recall details

Recalling firm

AGFA Corp.

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).

Action taken

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 debbie.norris@agfa.com. 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

Status

Terminated

Product code

LLZ

Quantity affected

280

Distribution

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

Date initiated

2011-06-06

Date posted

2011-11-18

Date terminated

2014-05-08

Location

Greenville, SC

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