RecallReported September 2, 2026
Class II recall by Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
FDA's enforcement report of September 2, 2026 lists a Class II recall by Philips Healthcare (Suzhou) Co., Ltd. of Suzhou, N/A. Product: Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. Status: Ongoing.
On the record
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Location
- Suzhou, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-2988-2026
- Product type
- Devices
- Recall initiated
- 2026-06-26
- Reported by FDA
- 2026-09-02
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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