Intelli-C, Left side suspended Tabletop, REF: 03400010 recallZ-1669-2023 · Nrt X-Ray A/S · initiated Apr 27, 2023

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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)

Recall details

Recall number

Z-1669-2023

Status

Open, Classified

Initiated by the company

Apr 27, 2023

Posted by the FDA

May 31, 2023

Recalling firm

Nrt X-Ray A/S

Quantity

13 units

Product code

OWB

FDA submissions

K173631

Distribution

US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.

Product description

Intelli-C, Left side suspended Tabletop, REF: 03400010

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Intelli-C Left Side Suspended Table 03400010

  Nrt - Nordisk Røntgen Teknik A/S · System, X-Ray, Fluoroscopic, Image-Intensified
  2 recalls1 report

Other devices under the same FDA submission

3 devices cleared under K173631 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Intelli-C Right Side Suspended Table 03400000

  Nrt - Nordisk Røntgen Teknik A/S · Interventional Fluoroscopic X-Ray System
  2 recalls0 reports
• Intelli-C Accessory 03282000

  Nrt - Nordisk Røntgen Teknik A/S · Interventional Fluoroscopic X-Ray System
  1 recall1 report
• Intelli-C Accessory 03283000

  Nrt - Nordisk Røntgen Teknik A/S · Interventional Fluoroscopic X-Ray System
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92230).

• Z-1668-2023 · Open, Classified
  Intelli-C, Right side suspended Tabletop, REF: 03400000