1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
Enforcement
- Recall Number
- Z-0526-2022
- Event ID
- 89413
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- NRT X-RAY A/S
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- February 2, 2022
- Initiation Date
- January 21, 2022
- Classification Date
- January 25, 2022
- Address
- Birkegardsvej 16, BIRKEGAARDSVEJ 16, Hasselager, N/A, Denmark
Description
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
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.
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
USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden
72 units