CLASS II ONGOING Device recall · Reported 2 Feb 2022 · FDA Enforcement Report

Footrest ( use exclusively in combination recalled by Nrt X-ray A/s

Nrt X-ray A/s is recalling Footrest ( use exclusively in combination with Intelli-C devices) Shoulder support ( use, distributed in 10 states. The recall was initiated on 21 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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

Quantity recalled72 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0526-2022
FDA event ID: 89413
Recalling firm: Nrt X-ray A/s, Hasselager
Classification: Class II
Status: Ongoing
Recall initiated: 21 Jan 2022
FDA classified: 25 Jan 2022
Reported: 2 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

21 Jan 2022	Recall initiated by company
25 Jan 2022	Classified by FDA	+4 days
2 Feb 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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

Iowa Kentucky Louisiana Massachusetts North Carolina New York Ohio South Carolina Washington West Virginia

Questions about this recall

Is Footrest ( use exclusively in combination with Intelli-C devices) Shoulder support ( use recalled?

Yes. Nrt X-ray A/s recalled Footrest ( use exclusively in combination with Intelli-C devices) Shoulder support ( use on 21 Jan 2022. The recall is Class II and its status is Ongoing. Recall number Z-0526-2022.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nrt X-ray A/s

All 4

Reported	Class	Recall	Company	Reason	Where
15 May 2024Device	CLASS II	Intelli-C: Right side suspended Tabletop recalled by Nrt X-ray A/s	Nrt X-ray A/s	Lead & Heavy Metals	Nationwide
7 Jun 2023Device	CLASS II	Intelli-C, Right side suspended Tabletop recalled by Nrt X-ray A/s	Nrt X-ray A/s	Device Malfunction	Nationwide
7 Jun 2023Device	CLASS II	Intelli-C, Left side suspended Tabletop recalled by Nrt X-ray A/s	Nrt X-ray A/s	Device Malfunction	Nationwide

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