Food, drugs, devices › Philips North America
Device recall: Incisive CT-Computed Tomography X-Ray System Model: 728143
Philips North America (Cambridge, MA) initiated this device recall on 25 Apr 2023; FDA lists 4 product records under event 92202, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Philips North America has 30 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips North America, Cambridge, MA.
Reason for recall
"Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down"
Distribution
"Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2258-2023 | Incisive CT-Computed Tomography X-Ray System Model: 728143 | 36 US; 610 OUS | Class II | Ongoing | 9 Aug 2023 |
| Z-2259-2023 | Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 | 20 units OUS | Class II | Ongoing | 9 Aug 2023 |
| Z-2260-2023 | Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 | 53 units OUS | Class II | Ongoing | 9 Aug 2023 |
| Z-2261-2023 | Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 | 6 units OUS | Class II | Ongoing | 9 Aug 2023 |
Context
Other enforcement events for Philips North America
All 30 events for Philips North America
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.