Recall Z-1784-2024 ยท OWB Interventional Fluoroscopic X-Ray System
NRT X-RAY A/S
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
| Date | May 7, 2024 (initiated Apr 17, 2024) |
| Status | Open, Classified |
| Reason | X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator. |
| Root cause | Device Design |
| Action | On 04/17/24, correction notices were emailed to consignees who were asked to do the following: 1) If you experience the described uncontrolled motion, stop using the device and contact your service provider to have your device repaired. 2) The correction notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. 3) Complete and return the response form to either support@nrtxray.com or servicesupport@alpha-imaging.com A firmware update will be made to all motor controllers in th |
| Quantity | 35 |
| Distribution | US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173631 | Intelli-C Nrt X-Ray A/S, Jul 11, 2018 |