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 | Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user. |
| Product | The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories |
| Quantity | 79 |
| Distribution | Worldwide Distribution - US including the states of : AZ, CA, CT, FL, GA,MA, MS,OH, PA, TX, and WY., and the countries of : Australia, Denmark, Finland, France, Germany, India, Ireland, Japan, Malaysia, Netherlands, New Zealand, Norway, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland and United Kingdom. |
| Initiated | 2014-09-11 |
| Classified | 2014-09-29 |
| Terminated | 2018-06-26 |
| Recall number | Z-2711-2014 |
| 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-2711-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69235/
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