RecallReported September 9, 2026
Class II recall by Philips North America Llc
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Softwar…
FDA's enforcement report of September 9, 2026 lists a Class II recall by Philips North America Llc of Cambridge, MA. Product: Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Softwar…. Status: Ongoing.
On the record
- Recalling firm
- Philips North America Llc
- Location
- Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3042-2026
- Product type
- Devices
- Recall initiated
- 2026-08-07
- Reported by FDA
- 2026-09-09
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.
More
Watch Philips North America Llc
A free account shows the last 7 days of every record. Pro adds a watchlist: one email when FDA acts on a company you name.
From FDA enforcement reports. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with Philips North America Llc.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.