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 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.
FDA Recall Z-2469-2018 · Posted None
Advertisement
Recalling FirmFx Solutions
Recall StatusTerminated
Product CodeHSD
Date Initiated2018-06-04
Date Terminated2019-04-05
Product Quantity145 units
Reason for Recall
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Firm Action
The firm initiated the recall by email on 06/04/2018 in France, on 06/05/2018, to distributors in the US and elsewhere. The distributor (US Agent) sent the notice on to the division agents who store the product. The firm requested return of the units.
Root Cause
Package design/selection
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement