La Ricamarie, N/A, France
Stephanix recalls
1 recall recorded since 2018, most recently on 2 November 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 November 2018
- Terminated
- 25 July 2021
- Reason
- The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
- Distribution
- US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0557-2019
- STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.