Class II — Philips Healthcare (Suzhou) Co., Ltd.
| Recalling firm | Philips Healthcare (Suzhou) Co., Ltd. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential of failing to trigger clinical scan during Bolus Tracking. |
| Product | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. |
| Quantity | N/A |
| Distribution | U.S. Nationwide and U.S. Territories distribution. |
| Initiated | 2026-06-26 |
| Classified | 2026-08-21 |
| Recall number | Z-2988-2026 |
| Initiation | FDA Mandated |
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 Healthcare (Suzhou) Co., Ltd. (Z-2988-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99511/
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