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 | One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware. |
| Product | Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system |
| Quantity | 2 |
| Distribution | One domestic and 1 foreign consignee ( Spain) |
| Initiated | 2017-11-01 |
| Classified | 2018-02-04 |
| Terminated | 2018-08-14 |
| Recall number | Z-0522-2018 |
| 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-0522-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79004/
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