FDA Medical Device Recalls (openFDA)
Fx Solutions: 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.
- Recall number
- Z-2469-2018
- Recalling firm
- Fx Solutions
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-06-04
- Posted
- not on file
- Terminated
- 2019-04-05
- Reason
- Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
- Root cause
- Package design/selection
- 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.
- Quantity
- 145 units
- 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
- Lot, serial or model codes
- UDI: 03701037300510 Lot Numbers: J1123, K231, K232, K233, K234, K235, K1117, K1118, K1418, K1419, K1625, L1271, L1272, L1727, L1729, L1736, L1747, L1755, L1819, M1041 France only: K532R, L1763
- 510(k) numbers
- ["K111097"]
- PMA numbers
- not on file
- Product code
- HSD
- Firm FEI
- 3009532798
- Firm city
- Viriat
- Firm state
- Rhone-Alpes
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28