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Philips Medical Systems (Cleveland) Inc recalls Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Recalled September 21, 2022 · FDA recall Z-1744-2022 · Philips Medical Systems (Cleveland)
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. · FDA Class II
Units
169 systems
Sold at
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.
Description
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.
Product
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →