Pinnacle3 Radiation Therapy Planning — Class II medical device recall Z-1312-2014
Terminated recall by Philips Medical Systems (Cleveland), Inc., reported 2014-04-09, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geome
| Recall number | Z-1312-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland), Inc., Fitchburg, WI, United States |
| Recall initiated | 2014-02-11 |
| Classified | 2014-03-31 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2014-11-21 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AT, AU, BE, CH, CN, DE, DK, ES, FR, GB, HK, HU, IE, IN, IT, JP, KR, LU, MX, MY, NL, NZ, OM, RU, TH, TR, TW |
| Quantity | 1,016 |
| Reason classes | software |
| Serial numbers | 0348AD10B2, 0841BD200F, 0908QAC00B, 0916QBD072, 0924QAC004, 0925QAD076, 0925QAD078, 0925QAD092, 0925QAD09E, 0926QAC016, 0926QAC01C, 0926QAC049, 0926QAC095, 0926QAD063, 0951QAD016, 101-SUN4140, 1029QAD06F, 1029QAD07C, 103, 1049FMMOGP, 1049FMMOKC, 1113FMMOR2, 1113FMMORB, 1113FMMORL, 1117FMM034 and 475 more |
Product
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Reason for recall
Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013.
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-1312-2014. 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.