Recall Z-0212-2012 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
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.
| Date | Nov 18, 2011 (initiated Jun 6, 2011) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Pending |
| 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 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 correction |
| Quantity | 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 of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |