CLASS II ONGOING Device recall · Reported 15 May 2024 · FDA Enforcement Report

Intelli-C: Right side suspended Tabletop recalled by Nrt X-ray A/s

Nrt X-ray A/s is recalling Intelli-C: Right side suspended Tabletop, distributed nationwide in the US. The recall was initiated on 17 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/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

Quantity recalled35

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1784-2024
FDA event ID: 94363
Recalling firm: Nrt X-ray A/s, Hasselager, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 17 Apr 2024
FDA classified: 7 May 2024
Reported: 15 May 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

17 Apr 2024	Recall initiated by company
7 May 2024	Classified by FDA	+20 days
15 May 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

Where it was distributed

US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI.

Nationwide Hawaii Iowa Kentucky Louisiana Massachusetts Michigan Minnesota North Carolina Nevada New York Pennsylvania South Carolina Washington Wisconsin West Virginia

Questions about this recall

Is Intelli-C: Right side suspended Tabletop recalled?

Yes. Nrt X-ray A/s recalled Intelli-C: Right side suspended Tabletop on 17 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-1784-2024.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nrt X-ray A/s

All 4

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Device	CLASS II	Intelli-C, Right side suspended Tabletop recalled by Nrt X-ray A/s	Nrt X-ray A/s	Device Malfunction	Nationwide
7 Jun 2023Device	CLASS II	Intelli-C, Left side suspended Tabletop recalled by Nrt X-ray A/s	Nrt X-ray A/s	Device Malfunction	Nationwide
2 Feb 2022Device	CLASS II	Footrest ( use exclusively in combination recalled by Nrt X-ray A/s	Nrt X-ray A/s	Foreign Material	10 states

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