Footrest accessory recalled for missing friction rubber block
FDA recalls Intelli-C footrest accessories due to missing friction rubber blocks in the clamping mechanism. The defect may cause the footrest to slip during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a structural defect (missing friction rubber block) that creates a risk of harm during patient procedures. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
The FDA has issued a Class II recall of footrest accessories designed for exclusive use with Intelli-C radiography devices. The affected footrests, manufactured by NRT X-RAY A/S, are missing the friction rubber block in the clamping mechanism. Without this component, the footrest may slip down along the patient table during use.
The recall affects 72 units distributed in the United States (IA, KY, LA, MA, NC, NY, OH, SC, WA, WV) and internationally (Switzerland, Czech Republic, Germany, Denmark, Netherlands, South Africa, and Sweden). Specific affected serial numbers have been identified by the manufacturer.
Facilities using the affected units should discontinue use of any footrest matching the recalled serial numbers and contact the manufacturer for replacement or repair instructions.
The recalled product
- Product
- 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
- Manufacturer
- NRT X-RAY A/S
- Affected units
- 72
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Footrest
- REF: 03282000
- UDI: 05713464000336
- Serial Numbers: 903282000046
- 903282000057
- 903282000075
- 9032820000070
- 903282000001
- 903282000002
- 903282000004 thru 903282000006
- 903282000009
- 903282000011
- 903282000012 903282000015
- 903282000016
- 903282000018 thru 903282000020
- 903282000023
- 903282000024
- 903282000025
- 903282000026
- 903282000028
Distribution
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