Philips recalls specific Pinnacle3 radiation therapy software versions due to incorrect dose calculations when multiple beams are used, potentially affecting treatment accuracy.
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.
Philips is recalling certain versions of its Pinnacle3 radiation therapy planning software because it can calculate incorrect radiation doses when multiple beams are attached to a treatment plan. This could lead to inaccurate radiation delivery during cancer treatment, which might affect treatment outcomes.
The software incorrectly calculates radiation doses when multiple beams are attached to a prescription and certain options are selected on the Edit Prescription screen. This could result in inaccurate radiation delivery during cancer treatment, potentially affecting treatment effectiveness or safety.
Healthcare providers using the recalled software versions for radiation therapy planning are most at risk. Patients receiving treatment with these specific software versions could be affected if their treatment plans are generated using the faulty software.
Check if your Pinnacle3 system has model numbers 870231 or 870237 with specific software versions listed in the recall notice. The affected versions include software versions 16.0.4, 16.4.2, 16.4.3, 16.4.6, and 18.0.1.
Verify your software version by checking the system's UDI (Unique Device Identification) information, which includes the software version number.
The software can calculate incorrect radiation doses when multiple beams are attached to a prescription and certain options are selected on the Edit Prescription screen, which could affect treatment accuracy.
Model 870231: Software versions 16.0.4, 16.4.2, 16.4.3. Model 870237: Software versions 16.4.6 and 18.0.1.
The recall does not specify any action steps beyond checking your software version. If you have the affected versions, you should contact Philips for further guidance.
We’ve drafted a message you can send Philips Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1744-2022 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-1744-2022 from Philips Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
