GEMINI TF PET/CT16: 882470 — Class II medical device recall Z-2037-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-07-16, distributed in CA, CO, IL, OK, OR, WI. When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator,
| Recall number | Z-2037-2014 |
|---|---|
| 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 | 2014-06-18 |
| Classified | 2014-07-10 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2015-09-16 |
| Distributed | CA, CO, IL, OK, OR, WI |
| Quantity | 33 |
Product
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. 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
When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not operational for clinical use. This problem occurs randomly.
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-2037-2014. 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.