FDA Device recall Z-0526-2022

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

FDA Device
Class II
ongoing
Published 2022-02-02

On 2022-02-02 the FDA classified a Class II recall of 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C de… by Nrt X Ray A S, citing 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 us….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0526-2022
Classification	Class II
Status	ongoing
Initiated	2022-01-21
Published	2022-02-02
Last updated	2026-09-13 11:56 UTC
Company	Nrt X Ray A S
Distribution	IA, KY, LA, MA, NC, NY, OH, SC, WA, WV

Product

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

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.

Identifiers

code_info	1. Footrest, REF: 03282000, UDI: 05713464000336; Serial Numbers: 903282000046, 903282000057, 903282000075 ,903282000… 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

code_info

1. Footrest, REF: 03282000, UDI: 05713464000336; Serial Numbers: 903282000046, 903282000057, 903282000075 ,903282000…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0526-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.