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.
Power cords may crack and fail inside plug with potential for fire hazard.
조치
Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product.
For further information, contact KCI's technical support team at 1-800-275-4524 option #3.
Device Serial Numbers: First Step All-In-One 35 Inch Canadian French - FTGK00001-FTGK00106; First Step All-In One 35-Inch English - FTCK00001-FTCK00624; Therakair Visio Canadian 800 Wids; Therakair Visio Canadian 900 Wids; Airworks Sure Std. 110V-Canada; Airworks Sure 80CM Wide, 110V - Canada; Product Assy-Provicare Std. 110V-Canada; and Product Assy-Proficare 80CM wide, 110V-Canada.
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268840 used with First Step All-In-One Canadian French Models 227500-09 and 227500, First Step All-In-One English Model 227500, Therakair Visio Models M8259978 and M6257763 pump only, and Proficare - Canada Model M8259988