Class 2 Device Recall Intelli C, Right / Intelli C, Left

• Date Initiated by Firm: January 21, 2022
• Create Date: January 25, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0526-2022
• Recall Event ID: 89413
• 510(K)Number: K173631
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
• Code Information: 1. Footrest, REF: 03282000, UDI: 05713464000336; Serial Numbers: 903282000046, 903282000057, 903282000075 ,9032820000070, 903282000001, 903282000002, 903282000004 thru 903282000006, 903282000009, 903282000011, 903282000012 903282000015, 903282000016, 903282000018 thru 903282000020, 903282000023, 903282000024, 903282000025, 903282000026, 903282000028, 903282000032 thru 903282000034, 903282000036, 903282000038 thru 903282000042, 903282000044, 903282000045, 903282000047 thru 903282000051, 903282000053, 903282000055, 903282000056, 903282000058 thru 903282000061, 903282000063, 903282000064, 903282000067, 903282000068 2. Shoulder Support, REF: 03283000, UDI: 05713464000381 Serial Numbers: 903283000012, 903283000028, 903283000001 thru 903283000003, 903283000005, 903283000010, 903283000011, 903283000013 thru 903283000022, 903283000023, 903283000024, 903283000026
• FEI Number: 1000188474
• Recalling Firm/ Manufacturer: NRT X-RAY A/S; Birkegardsvej 16; BIRKEGAARDSVEJ 16; Hasselager Denmark
• For Additional Information Contact: Kevin Smith; 300-696-0004
• Manufacturer Reason for Recall: Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.
• FDA Determined Cause: Process control
• Action: On 01/11/2022, NRT issued an Urgent Medical device correction, which includes the following action to be taken by the users. 1. Identified the affected accessories as described in the Urgent Medical Device Correction Letter. 2. Inspect the Footrest and Shoulder Support which use the same clamping mechanism and should be inspected in the same way. The clamping mechanism consists of two clamping profiles, one for each side of the tabletop. Both sides should be inspected. a. The friction rubber that must be inspected is placed inside the clamping profile. It is the thick rubber, which must be firmly in place. The rubber is glued on the profile, and you should look for the overall adhesion. If slightly pressed from each side and end, the rubber should not show signs of detachment from the profile. If the rubber is firmly in place, you may continue use the equipment. If the rubber is detaching along either side or end, do not use the accessory until the repair has been made. 3. Return the response card in page 4, with the results and date of the inspection and your signature, not later than February 15, 2022. to support@nrtxray.com. 4. Follow up will be made in regards to the repair in April 2022, which will be coordinated with US dealer Alpha Imaging in Willoughby, Ohio. For any question contact (300) 696-0004 or E-Mail at ksmith@alpha-imaging.com.
• Quantity in Commerce: 72 units
• Distribution: USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden
• Total Product Life Cycle: TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB