Recall Z-0526-2022— NRT X-RAY A/S
Class II · Ongoing
Class II FDA medical device recall by NRT X-RAY A/S, initiated 2022-01-21. It names one FDA 510(k) clearance: K173631. Product: 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices). Reason: 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..
- Recalling firm
- NRT X-RAY A/S
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-21
- Firm location
- Hasselager, Denmark
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.