Recall Z-2468-2018— Fx Solutions
Class II · Terminated
Class II FDA medical device recall by Fx Solutions, initiated 2018-06-04, terminated 2019-04-05. It names one FDA 510(k) clearance: K111097. Product: 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 treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.. Reason: Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19..
- Recalling firm
- Fx Solutions
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-04
- Terminated
- 2019-04-05
- Firm location
- Viriat Rhone-Alpes, France
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
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 treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Reason for recall
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Data sourced from openFDA. This site is unofficial and independent of the FDA.