FDA-Device2022-02-02Class II
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
NRT X-RAY A/S
Hazard
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.
Sold states
USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden
Affected count
72 units
Manufactured in
Birkegardsvej 16, BIRKEGAARDSVEJ 16, Hasselager, Denmark
Products
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0526-2022Don't want to check this manually?
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