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 | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment. |
| Product | Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body. |
| Quantity | 380 Units |
| Distribution | Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland… |
| Initiated | 2016-04-29 |
| Classified | 2016-08-10 |
| Terminated | 2018-07-02 |
| Recall number | Z-2384-2016 |
| 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-2384-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74131/
Alerts for Philips Medical Systems International BV
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.