Z-1784-2024Class II

Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used...

Name: Z-1784-2024 Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used...
Creator: Nrt X-Ray a/s
Published: 2024-04-17
License: https://open.fda.gov/license/

NRT X-Ray a/S / initiated 2024-04-17 / Open, Classified / root cause: design

FDA source

NRT X-RAY A/S began a recall of Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system on 2024-04-17. FDA classified it as Class II and gives the reason as "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...". 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-1784-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-17
Posted: 2024-05-07
Recalling firm: NRT X-Ray a/S
Product: Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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 tag: design
FDA 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 [email protected] or [email protected] A firmware update will be made to all motor controllers in the system. The update will be performed by the Service Provider. Customers with recall-related questions can call 1-800-331-7327.
Quantity in commerce: 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.
Product codes and lots: REF/UDI-DI/Serial Numbers: 03400000/05713464000527/627002, 627004, 627007, 639001, 639002, 639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651007, 658002, 658003, 658006, 658010, 666008, 675001, 675004, 682006, 682010, 682011, 696003, 696004, 696006, 696007, 696012. 03400010/05713464000121/647009, 651002, 651006, 666009, 682003, 682023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1784-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1784-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-07

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)