Viriat Rhone-Alpes, France
Fx Solutions recalls
1 recall recorded since 2018, most recently on 4 June 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
- 4 June 2018
- Terminated
- 5 April 2019
- Reason
- Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: France, Argentina, South Africa, Spain, Israel, Germany, Lebanon, Italy, Chile, Belgium, Greece, Mexico, Poland, Hong Kong, Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2468-2018, Z-2469-2018
- Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatme
- Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment
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.