Z-1668-2023Class II

Intelli-C, Right side suspended Tabletop, REF: 03400000

Name: Z-1668-2023 Intelli-C, Right side suspended Tabletop, REF: 03400000
Creator: Nrt X-Ray a/s
Published: 2023-04-27
License: https://open.fda.gov/license/

NRT X-Ray a/S / initiated 2023-04-27 / Open, Classified / root cause: design

FDA source

NRT X-RAY A/S began a recall of Intelli-C, Right side suspended Tabletop, REF: 03400000 on 2023-04-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1668-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-27
Posted: 2023-05-31
Recalling firm: NRT X-Ray a/S
Product: Intelli-C, Right side suspended Tabletop, REF: 03400000
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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 tag: design
FDA 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 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)
Quantity in commerce: 32 units
Distribution: US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
Product codes and lots: UDI-DI: 05713464000527/Serial Numbers: 627004, 627007, 639001, 639002,639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651007, 658002, 658003, 658006, 658010, 666008, 675001, 675004, 682006, 682010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1668-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1668-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-31
Z-1669-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-31

Product code OWB

K173631Class IIIntelli-CNrt X-Ray A/S / cleared 2018-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)