GEMINI LXL CT/PET System — Class II medical device recall Z-2194-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-07-29, distributed nationwide. Philips has identified four (4) software defects in the Tumor LOC software application that may potentially re
| Recall number | Z-2194-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2015-07-01 |
| Classified | 2015-07-22 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2018-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, CN, DE, DK, FR, IL, IT, JP, LB, NL, PT, SA, TH, VE, VN, ZA |
| Quantity | 2 units |
| Reason classes | software |
| Serial numbers | 14702, 14707 |
| Model numbers | 882412 |
Product
GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Reason for recall
Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
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-2194-2015. 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.