CLASS II ONGOING Device recall · Reported 21 Sep 2022 · FDA Enforcement Report
Pinnacle3 Radiation Therapy Planning System recalled
Philips Medical Systems (Cleveland) is recalling Pinnacle3 Radiation Therapy Planning System, distributed in 21 states. The recall was initiated on 30 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1744-2022
- FDA event ID
- 90819
- Recalling firm
- Philips Medical Systems (Cleveland), Gainesville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Aug 2022
- FDA classified
- 15 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Aug 2022 | Recall initiated by company | |
| 15 Sep 2022 | Classified by FDA | +16 days |
| 21 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Where it was distributed
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.
CaliforniaFloridaGeorgiaIowaIllinoisMassachusettsMarylandMaineMichiganMinnesotaNew JerseyNew MexicoNevadaNew YorkOhioOklahomaRhode IslandSouth CarolinaTennesseeTexas
Questions about this recall
Why was it 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 lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems (Cleveland)
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|---|---|---|---|---|---|
| Device | CLASS II | Pinnacle Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Packaging Defects | Nationwide |
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| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
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