Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for pre-hospital pat

FDA device recall Z-2826-2015 · posted 2015-10-01 · Terminated

Recall details

Recalling firm

Ferno-Washington Inc

Reason for recall

Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame.

Action taken

Ferno began calling their customers on 8/3/2015. The firm informed their customers of the following: To provide optimal Customer Experience and minimal disruption to your service, the iNX field action involves the following steps: " Exchange of your current iNX with a new iNX; " Participation in a brief training session; and " Inspection of your Ferno Model 175 antler and rail fastening system as requested by the Dept. of Transportation. As you await delivery of your new iNX, it is important you ensure proper function of the fastening system and iNX telescoping load frame.

Root cause

Device Design

Status

Terminated

Product code

FPO

Quantity affected

72 units

Distribution

Worldwide Distribution - US Nationwide in the states of: CO, IA, IL, IN, KY, MD, MN, MO, NC, NJ, NY, OH, OK, OR, TX, VA, WA & WY and the countries of CANADA, AUSTRALIA, UNITED KINGDOM & NEW ZEALAND.

Date initiated

2015-08-03

Date posted

2015-10-01

Date terminated

2016-01-20

Location

Wilmington, OH