IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for cathe
FDA device recall Z-1070-2013 · posted 2013-04-08 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.
- Action taken
- AGFA sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013 to the consignees who use the IMPAX CV Reporting tool described for this issue. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 877-777-2432, referencing HQ_10020006 for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 26
- Distribution
- Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.
- Date initiated
- 2013-03-15
- Date posted
- 2013-04-08
- Date terminated
- 2014-01-09
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, Inc. | 2005-02-18 |