NRT X-RAY A/S Recall 89413
Description: 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
NRT X-RAY A/S Recall 89413 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0526-2022 |
| Event ID | 89413 |
| Event Description | 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices) |
| Product Type | Devices |
| Distribution | USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden |
| Quantity | 72 units |
| Recall 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. |
| Device Classification | 20220202 |
| Device 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 |
| Center Classification Date | 20220125 |
| Recall Initiation Date | 20220121 |
| Recalling Firm | NRT X-RAY A/S |
| Initial Notification | |
| Similar To |