Z-0526-2022Class II

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

Name: Z-0526-2022 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in...
Creator: Nrt X-Ray a/s
Published: 2022-01-21
License: https://open.fda.gov/license/

NRT X-Ray a/S / initiated 2022-01-21 / Open, Classified / root cause: manufacturing process

FDA source

NRT X-RAY A/S began a recall of 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices) on 2022-01-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0526-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-21
Posted: 2022-01-25
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)
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 [email protected].
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0526-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0526-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-02	2022-01-25

Product code OWB

K173631Class IIIntelli-CNrt X-Ray A/S / cleared 2018-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)