Device product
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Z-1744-2022
Product summary
- Event
- Event 90819
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 169 systems
- Official record key
device-enforcement:Z-1744-2022
Official wording
Reason: When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
Code information: Model 870231: Software version 16.0.4, UDI (01)00884838099081(10)16.0.4.60330; Software version 16.4.2, UDI (01)0084838103054(10)16.4.2.60330, UDI (01)00884838102965(10)16.4.2.60330, UDI (01)00884838102972(10)16.4.2.60315, UDI (01)00884838102989(10)16.4.2.60330; UDI (01)00884838103191(10)16.4.2.60330; and Software version 16.4.3, UDI (01)00884838102965(10)16.4.3.60360. Model 870237: Software version 16.4.6, UDI (01)00884838103566(10)16.4.6.21197; and Software version 18.0.1, UDI (01)00884838103566(10)18.0.1.2149 and (01)00884838103566(10)18.0.1.21197.
Distribution pattern: Distribution was made to CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, OK, RI, SC, TN, TX, and WA. There was government distribution and no military distribution. Foreign distribution was made to Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Jordan, Lebanon, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, and United Kingdom.
Derived failure modes
-
Unknown
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.