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 system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients. |
| Product | Ingenuity TF PET/CT. Diagnostic imaging system |
| Quantity | 1 Unit |
| Distribution | Distributed only in Ohio. |
| Initiated | 2013-01-21 |
| Classified | 2013-02-28 |
| Terminated | 2013-07-19 |
| Recall number | Z-0897-2013 |
| 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-0897-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64403/
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