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U.S. Department of Health and Human Services

Class 2 Device Recall iNX Wheeled Stretcher

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 Class 2 Device Recall iNX Wheeled Stretchersee related information
Date Initiated by FirmAugust 03, 2015
Date PostedOctober 01, 2015
Recall Status1 Terminated 3 on January 20, 2016
Recall NumberZ-2826-2015
Recall Event ID 71983
Product Classification Stretcher, wheeled - Product Code FPO
ProductFerno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for pre-hospital patient transport.
Code Information Serial #s: 15F001703, 15F001704, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001715, 15F001717, 15F001719, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001728, 15F001729, 15F001730, 15F001731, 15F001732, 15F001733, 15F001734, 15F001735, 15F001736, 15F001737, 15F001738, 15F001739, 15F001740, 15F001741, 15F001742, 15F001744, 15F001745, 15F001746, 15F001747, 15F001748, 15F001749, 15F001750, 15F001751, 15F001752, 15F001753, 15F001754, 15F001755, 15F001756, 15F001757, 15F001758, 15F001759, 15F001760, 15F001761, 15F001762, 15F001763, 15F001764, 15F001765, 15F001766, 15F001767, 15F001768, 15F001769

5F001770, 15F001771, 15F001772, 15F001773, 15F001774, 15F001775, 15F001776, 15F001777, 15F001778, 15F001779, 15F001780, 15F001781, 15F001782, 15F001783, 15F001784, 15F001785, 15F001786, 15F001787, 15F001788, 15F001789, 15F001790, 15F001791, 15F001793, 15F001794, 15F001795, 15F001796, 15F001797, 15F001798, 15F001804, 15F001805, 15F001806, 15F001807, 15F001808, 15F001809, 15F001810, 15F001811, 15F001812, 15F001813, 15F001814, 15F001815, 15F001816 & 15F001850.
Recalling Firm/
Manufacturer		 Ferno-Washington Inc
70 Weil Way
Wilmington OH 45177-9371
For Additional Information ContactMrs. Dorothy A. Deaton
937-283-2885
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionFerno 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.
Quantity in Commerce72 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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