Z-2592-2017 Class II Terminated
FDA device recall Z-2592-2017 was initiated by Ion Beam Applications S.A. on February 9, 2017 and is designated Class II. Reason for recall: It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mo… The recall status is terminated (terminated July 14, 2023). Affected quantity: 18 systems ( 10 in the US).
Recall Details
- Product Type
- Devices
- Report Date
- June 28, 2017
- Initiation Date
- February 9, 2017
- Termination Date
- July 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 systems ( 10 in the US)
Product Description
Proteus 235
Reason for Recall
It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.
Distribution Pattern
Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
Code Information
Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126