FDA Device recall Z-1744-2022
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237
- FDA Device
- Class II
- ongoing
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class II recall of Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237 by Philips Medical Systems Cleveland, citing 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 sel….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1744-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-30 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, OK, RI, SC, TN, TX, WA |
Product
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Reason
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.
Identifiers
| code_info | Model 870231: Software version 16.0.4, UDI (01)00884838099081(10)16.0.4.60330; Software version 16.4.2, UDI (01)00848…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Philips Medical Systems Cleveland
- Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.2…
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All Philips Medical Systems Cleveland recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1744-2022%22
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