U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Wheelchair, mechanical - Product Code IOR
원인
Gunnell has received complaints that the gas cylinders used in gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the rehab tough and tilt (tnt), bariatric rehab tough and tilt (btnt), rehab recline and mobility (ram), bariatric rehab recline and mobility (bram), and rehab kidster.
조치
Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to andy.evancho@gunnell-inc.com. or call 1-800-551-0055, attention Andy Evancho.
Worldwide Distribution - USA (nationwide) nad the countries of: Australia and Canada
제품 설명
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Tough and Tilt (TNT). || Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.