Greenville, SC August 15, :00 EST

Transcription

1 PRESS RELEASE Agfa HealthCare Corporation 10 South Academy Street Greenville SC Miriam Ladin Director, Marketing Communications North America Kimberley Sirk Specialist, Marketing Communications North America Agfa HealthCare Issues Nationwide Communication of DX-D 100 Mobile X-ray and Other Medical Device Products Damaged by Hurricane Sandy in 2012 Greenville, SC August 15, :00 EST Agfa HealthCare Corporation (Agfa), Greenville, South Carolina, is initiating this nationwide communication regarding certain medical devices that were damaged by Hurricane Sandy in The medical devices in question had been stored in Agfa's Carlstadt, New Jersey warehouse in October The warehouse flooded during Hurricane Sandy, and the building and some of the inventory stored in the building experienced major water and mold damage. Agfa made arrangements with a third party contractor to have the medical devices in question be destroyed or recycled. However, some of the products from this inventory recently have been discovered by Agfa to be in the U.S. market and were apparently not destroyed, as Agfa had instructed. Agfa hereby advises healthcare consumers and buyers that due to contamination and water damage, these devices are not suitable for use in any facility environment for testing, patient care or diagnostic purposes and may pose a risk to patients and users. Additionally, the DX-D 100 Mobile X-ray products from this inventory (identified by serial number in the list below), do not have the mandatory service corrections and labeling that Agfa had issued after October 2012, which are required by the U.S. Food & Drug Administration ( U.S. FDA ) and other regulatory authorities for these devices. This inventory should have been destroyed and should not be present in the market, and Agfa will not be responsible for requests for service or quality issues that may occur with these specific DX-D 100 Mobile X-ray units or any of the other medical devices from this damaged inventory (listed below with serial numbers). The U.S. FDA has been apprised of this action. No injuries have been reported to date arising from use of any of the products in this Hurricane Sandy-damaged stock. 1/7

2 Consumers or buyers who have any of the products listed in this communication should stop using the products immediately and should not sell the product to anyone. Consumers or buyers with questions may contact Agfa HealthCare anytime, 24/7 at: Dial: Press: 1 for Support Tickets; then 4 for Imaging Call Center Any adverse reactions experienced with the use of any of these medical device products, and/or quality problems should also be reported to the FDA s MedWatch Program by phone at FDA- 1088, by Fax at FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD , or on the MedWatch website at Line Items Medical Devices Serial Number QTY 1 DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A DX-D 100 A /7

3 24 DX-D 100 A DX-D 100 A TOTAL DX-D CR 85-X CR 85-X CR 85-X CR 85-X CR 85-X TOTAL CR 85-X 5 31 CR 35-X CR 35-X CR 35-X CR 35-X CR 35-X TOTAL CR 35-X 5 36 CR 30-X CR 30-X CR 30-X TOTAL CR 30-X 3 39 CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ CR10-X 5151/ /7

4 TOTAL CR10-X DRYSTAR / DRYSTAR / DRYSTAR / DRYSTAR DRYSTAR DRYSTAR DRYSTAR DRYSTAR DRYSTAR AXYS 5367/ DRYSTAR AXYS 5367/ DRYSTAR AXYS 5367/ DRYSTAR AXYS 5367/ DRYSTAR AXYS 5367/ DRYSTAR AXYS 5367/ DRYSTAR AXYS 5367/ DRYSTAR AXYS 5367/ DRYSTAR AXYS 5367/ DRYSTAR AXYS 5367/ DRYSTAR AXYS 5367/ AXYS DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C /7

5 85 DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C A DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C DX-D 30C TOTAL DX-D 30C DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M /7

6 122 DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M DX-M CARL DX-M DX-M DX-M DX-M TOTAL DX-M DX-G TOTAL DX-G DRYSTAR / / Varian Detector CSI NQ02 1 TOTAL Varian Detector CSI 1 About Agfa HealthCare Agfa HealthCare, is a leading provider of ehealth & Digital Imaging solutions. Agfa HealthCare s solutions are at work in leading hospitals and health systems across the globe, allowing users to optimize their efficiency and improve patient care. For more information on Agfa HealthCare, please visit or the Agfa HealthCare Blog For images, courtesy of Agfa HealthCare, please visit Follow us at Twitter Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V. Belgium or its affiliates..all rights reserved. All information contained herein is intended for guidance purposes only, and characteristics of the products and services described in this publication can be changed at any time without notice. Products and services may not be available for your local area. Please contact your local sales representative for availability 6/7

7 information. Agfa HealthCare diligently strives to provide as accurate information as possible, but shall not be responsible for any typographical error. 7/7