Pinnacle3 Radiation Therapy Planning System — Class II medical device recall Z-1744-2022
Ongoing recall by Philips Medical Systems (Cleveland) Inc, reported 2022-09-21, distributed in CA, FL, GA, IA, IL, MA, MD, ME…. When computing a radiation dose in the system, the exported dose information is incorrect when there is more t
| Recall number | Z-1744-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Gainesville, FL, United States |
| Recall initiated | 2022-08-30 |
| Classified | 2022-09-15 |
| Reported by FDA | 2022-09-21 |
| Distributed | CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, OK, RI, SC, TN, TX, WA |
| Countries outside the US | AT, AU, BE, CH, CN, DE, ES, FR, GB, IT, JO, JP, LB, PL, PT, RO, SG, TH, TW |
| Quantity | 169 systems |
| UPC / GTIN / UDI-DI | 00884838099081, 00884838102965, 00884838102972, 00884838102989, 00884838103191, 00884838103566 |
| Model numbers | 870231, 870237 |
Product
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1744-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.