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 | It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data. |
| Product | Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). |
| Quantity | 10 units |
| Distribution | Worldwide Distribution -- US, including the states of NY, OH, & TX; and, the countries of Finland, Germany, Japan, Netherlands, South Korea, Spain, & Switzerland. |
| Initiated | 2015-03-11 |
| Classified | 2015-05-28 |
| Terminated | 2018-06-26 |
| Recall number | Z-1682-2015 |
| 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-1682-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71228/
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