Philips 459801050602Recalls & reported problems

Philips Medical Systems (cleveland), Inc. · Pinnacle Radiation Therapy Planning System Version 16.0.1.60003 · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K170086); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Aug 5, 2025Open, Classified
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Z-2570-2025 · Root cause: Software design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170086. One submission often covers many models, so check the product and lot details in each record.

Z-2239-2025 · Jul 17, 2025 · Open, Classified
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Z-1744-2022 · Aug 30, 2022 · Open, Classified
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.

Device details

UDI-DI	`00884838085602`
Brand	Philips
Model	459801050602
Company	Philips Medical Systems (cleveland), Inc.
Product code	MUJ · System, planning, radiation therapy treatment
Class	Class 2
FDA submission	K170086
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Sep 18, 2025

Device type (GMDN): Radiation therapy software

An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.