1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
Check against the official notice below — it lists the full affected range.
NRT X-RAY A/S is recalling Footrest and Shoulder Support accessories designed for use exclusively with Intelli-C devices (Right and Left models). The Footrest units in this recall are missing a friction rubber block in the clamping mechanism, which could cause the footrest to slip down along the patient table during use with a patient. A total of 72 units have been distributed across multiple states in the USA (Iowa, Kentucky, Louisiana, Massachusetts, North Carolina, New York, Ohio, South Carolina, Washington, and West Virginia) and internationally in Switzerland, Czech Republic, Germany, Denmark, Netherlands, South Africa, and Sweden.
The affected Footrest units have reference number 03282000 and specific serial numbers listed in the recall documentation, along with affected Shoulder Support units with reference number 03283000. The source document does not specify a remedy for consumers who have received these products.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden Quantity: 72 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.