Recall Z-1668-2023 ยท OWB Interventional Fluoroscopic X-Ray System
NRT X-RAY A/S
Intelli-C, Right side suspended Tabletop, REF: 03400000
| Date | May 31, 2023 (initiated Apr 27, 2023) |
| Status | Open, Classified |
| Reason | There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop. |
| Root cause | Device Design |
| Action | Between the dates of April 27, 2023 - May 1, 2023, NRT X-Ray A/S issued a "urgent: Medical Device Correction" via E-Mail to affected consignees. Per the customer communication, NRT ask consignees to take the following actions: Step 1 Short term action The first step of the recall is a corrective action which requires the existing fixation bracket components to be removed. Service Providers of the Intelli-C systems should follow the instructions in page 4 through 7 of the communication and report back to NRT using the Customer Response Card on page 8. The process is coordinated through US d |
| Quantity | 32 units |
| Distribution | US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173631 | Intelli-C Nrt X-Ray A/S, Jul 11, 2018 |