Recall Z-0526-2022 ยท OWB Interventional Fluoroscopic X-Ray System
NRT X-RAY A/S
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
| Date | Jan 21, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On 01/11/2022, NRT issued an Urgent Medical device correction, which includes the following action to be taken by the users. 1. Identified the affected accessories as described in the Urgent Medical Device Correction Letter. 2. Inspect the Footrest and Shoulder Support which use the same clamping mechanism and should be inspected in the same way. The clamping mechanism consists of two clamping profiles, one for each side of the tabletop. Both sides should be inspected. a. The friction rubber that must be inspected is placed inside the clamping profile. It is the thick rubber, w |
| Quantity | 72 units |
| Distribution | USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173631 | Intelli-C Nrt X-Ray A/S, Jul 11, 2018 |