FDA recall Z-1744-2022

Philips Medical Systems (Cleveland) Inc · Class II · device

Product

Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.

Reason for recall

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2022-08-30
Report date
2022-09-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1744-2022