FDA-Device2022-09-21Class II
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Philips Medical Systems (Cleveland) Inc
Hazard
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.
Sold states
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.
Affected count
169 systems
Manufactured in
3630 Sw 47th Ave, Gainesville, FL, United States
Products
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1744-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief