Class II — Philips Medical Systems (Cleveland) Inc
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 264 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : 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, and WY., and to the countries of : Canada, Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Luxembourg, Mexico, Netherlan… |
| Initiated | 2008-05-01 |
| Classified | 2015-11-02 |
| Terminated | 2015-11-06 |
| Recall number | Z-0197-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems (Cleveland) Inc (Z-0197-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69082/
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