Intelli-C Accessory 03282000Recalls & reported problems
Nrt - Nordisk Røntgen Teknik A/S · Footrest for the Intelli-C X-ray system to support the patient during table top angulation. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05713464000336), received between Jan 21, 2022 and Jan 21, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Slipped” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (K173631); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jan 21, 2022Open, Classified
Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.
Z-0526-2022 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Device Slipped1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2022Device Slipped
IT WAS REPORTED THAT THE FOOTREST SLID DOWN ALONG THE PATIENT TABLE WHILE IN USE WITH A PATIENT. THE PATIENT GRABBED THE PATIENT TABLE AND DID NOT FALL.
Patient problems: Insufficient Information
MAUDE report 13318352 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K173631. One submission often covers many models, so check the product and lot details in each record.
- Z-1784-2024 · Apr 17, 2024 · Open, ClassifiedIntelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
- Z-1669-2023 · Apr 27, 2023 · Open, ClassifiedIntelli-C, Left side suspended Tabletop, REF: 03400010
- Z-1668-2023 · Apr 27, 2023 · Open, ClassifiedIntelli-C, Right side suspended Tabletop, REF: 03400000
Other Interventional Fluoroscopic X-Ray System devices
- Allura Xper FD Allura Xper FD20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System25 recalls2 deaths3,984 reports
- Allura Xper FD Allura Xper FD20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths3,614 reports
- Azurion Azurion 7 M20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System32 recalls2 deaths2,308 reports
- O-ARM® BI70002000Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system2 recalls1 death3,667 reports
- Azurion Azurion 7 M20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System28 recalls1 death2,176 reports
- Allura Xper FD Allura Xper FD10Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths2,015 reports
- Allura Xper FD Allura Xper FD10Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System20 recalls2 deaths1,837 reports
- Azurion Azurion 7 M12Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System24 recalls2 deaths1,087 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.