NRT X-RAY A/S: 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)

Recall number

Z-0526-2022

Recalling firm

NRT X-RAY A/S

Product

1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)

Status

Open, Classified

Initiated

2022-01-21

Posted

not on file

Terminated

not on file

Reason

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.

Root 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

72 units

Distribution

USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden

Lot, serial or model codes

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

510(k) numbers

["K173631"]

PMA numbers

not on file

Product code

OWB

Firm FEI

1000188474

Firm city

Hasselager

Firm state

not on file

Firm country

Denmark

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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