Intelli-C, Right side suspended Tabletop, REF: 03400000
Recall
- Recall Number
- Z-1668-2023
- Event Number
- 92230
- Firm
- NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark
- FEI Number
- 1000188474
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- April 27, 2023
- Posted
- May 31, 2023
Description
Intelli-C, Right side suspended Tabletop, REF: 03400000
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.
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 dealer Alpha Imaging in Willoughby, Ohio. Step 2 Long term action The second step is a preventive action to replace the IDE drive shaft and relating components. A separate set of instructions for this action will be provided in May together with the required parts for the replacement. These instructions will include a separate acknowledgement form for this action. If you have questions regarding the contents of this letter, please contact your local Service provider or contact NRT X-RAY A/S directly using the following contact information: Email: [email protected] Phone: +45 2055 3309 Monday through Friday, (03:00)-11:00 Eastern Standard Time (9:00 AM to 5:00 PM, Central European Time)
US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
32 units