IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates...

FDA Device Recall #Z-1070-2013 — Class II — March 15, 2013

Recall Summary

Recall Number Z-1070-2013
Classification Class II — Moderate risk
Date Initiated March 15, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm AGFA Corp.
Location Greenville, SC
Product Type Devices
Quantity 26

Product Description

IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.

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.

Distribution Pattern

Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.

Lot / Code Information

Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL

Other Recalls from AGFA Corp.

Recall # Classification Product Date
Z-2081-2014 Class II AGFA Digital Radiography X-Ray system DX-D 100 ... Jun 6, 2014
Z-1662-2014 Class II IMPAX CV Pediatric Echo Reporting, IMPAX CV Ech... Apr 30, 2014
Z-0919-2014 Class II IMPAX RIS QDOC 5.8 Jan 8, 2014
Z-0035-2014 Class II IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0)... Sep 19, 2013
Z-1487-2013 Class II AGFA Digital Radiography X-Ray System DX-D 100 ... May 15, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.