Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Reported: September 21, 2022 Initiated: August 30, 2022 #Z-1744-2022
Product Description
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.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 169 systems
- 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.
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 169 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2022. Severity: Moderate. Recall number: Z-1744-2022.
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