FDAFDA · Food and drugs·Recall number Z-1744-2022
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Published September 21, 2022 · Recall initiated: August 30, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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