Class III — 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 III |
| Status | Terminated |
| Reason | The product label does not include the correct current rating. |
| Product | IQon Spectral CT Computed Tomography X-ray system, Model 728332 |
| Quantity | 3 |
| Distribution | Worldwide distribution. The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT. There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS… |
| Initiated | 2016-10-13 |
| Classified | 2016-11-16 |
| Terminated | 2018-06-29 |
| Recall number | Z-0598-2017 |
| 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 III recall — Philips Medical Systems (Cleveland) Inc (Z-0598-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75516/
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