Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Summary
The FDA issued a Class II for Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software by Philips Medical Systems (Cleveland) Inc. Reason: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR).
Details
Source
Device Recall
External ID
Z-2239-2025
Action Date
2025-08-13
Status
Ongoing
Category
device
Product Description
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Lot/Code Info: Software Version Number: 18.0.5/UDI: (01)00884838103566
Quantity Affected: 149 Serial Numbers
Reason for Recall
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Distribution
Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-17
Company
Gainesville, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 172 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Medical Systems (Cleveland) Inc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Medical Systems (Cleveland) Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Medical Systems (Cleveland) Inc have FDA actions?
Philips Medical Systems (Cleveland) Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2239-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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