FDA recall Z-0526-2022

NRT X-RAY A/S · Class II · device

Product

1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)

Reason for recall

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.

Distribution

USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden

Key facts

Status: Ongoing
Initiation date: 2022-01-21
Report date: 2022-02-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hasselager, Denmark

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0526-2022