Reported Feb 2, 2022 · Ongoing
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in…
Nrt X-Ray A/s
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NRT X-RAY A/S · Birkegardsvej 16 · Hasselager · N/A
Is this the product you have?
- 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
- Lot codes and dates
- 1. Footrest
- REF03282000
- UDI05713464000336
- Serial Numbers
9032820000469032820000579032820000759032820000070903282000001903282000002903282000004 thru 903282000006903282000009903282000011903282000012 903282000015903282000016903282000018 thru 903282000020903282000023903282000024903282000025903282000026903282000028903282000032 thru 903282000034903282000036903282000038 thru 903282000042903282000044903282000045903282000047 thru 903282000051903282000053903282000055903282000056903282000058 thru 903282000061903282000063903282000064903282000067903282000068 2. Shoulder Support
- REF03283000
- UDI05713464000381
- Serial Numbers
903283000012903283000028903283000001 thru 903283000003903283000005903283000010903283000011903283000013 thru 903283000022903283000023903283000024903283000026
- Amount recalled
- 72 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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