Recall Z-2552-2011 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting.
| Date | Jun 10, 2011 (initiated Mar 21, 2011) |
| Status | Terminated |
| Reason | Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration. |
| Root cause | Other |
| Action | The firm, AGFA Healthcare, sent an "URGENT SAFETY NOTICE" letter dated March 21, 2011 via FED-EX to its customers.. The letter describes product, problem, and actions to be taken. The customers were instructed to distribute this information within their facility to all individuals who need to be aware and to complete and return the URGENT SAFETY NOTICE FEEDBACK FORM via fax to: 864-421-1664 or email. AGFA is supplying the customers with a CRS User Manual Addendum to emphasize the proper steps required to achieve an accurate measurement when using the calibration tool within CRS. Mitigati |
| Quantity | 536 |
| Distribution | Worldwide distribution: USA (nationwide) 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 |