GEMINI PET/CT System — Class II medical device recall Z-0197-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-11-11, distributed in AL, AZ, CA, CO, DE, FL, GA, HI…. The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of p
| Recall number | Z-0197-2016 |
|---|---|
| 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 | 2008-05-01 |
| Classified | 2015-11-02 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2015-11-06 |
| Distributed | AL, AZ, CA, CO, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CN, DE, DK, ES, FI, FR, GB, HK, IL, IT, JO, JP, KR, LU, MX, NL, PL, PT, SE, TH, TR, TW, ZA |
| Quantity | 264 units |
Product
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Reason for recall
The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
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-0197-2016. 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.