Saint Louis, MO, United States
Stereotaxis Inc recalls
1 recall recorded since 2018, most recently on 21 September 2020. 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
- 21 September 2020
- Terminated
- 13 November 2023
- Reason
- There is a potential for fire in the inside computer cabinet.
- Distribution
- US and OUS distribution: US - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ, NY, GA, ID, OK, CO, LA OUS - EU, China, Australia, Singapore, Canada, South Africa, and Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0430-2021
- Niobe ES System, Models 001-006000-1 and 001-006100-1
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.