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Terminated

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

FDA Recall Z-2826-2015 · Posted 2015-10-01

Recalling FirmFerno-Washington Inc
Recall StatusTerminated
Product CodeFPO
Date Initiated2015-08-03
Date Terminated2016-01-20
Product Quantity72 units

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.

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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