FDA Medical devices recall ·
Philips Incisive CT with software V4.5&V5.0… recall
- Recall number
- Z-2988-2026
- Date
- (initiated June 26, 2026)
- Company / brand
- Philips Healthcare (Suzhou) Co., Ltd.
Suzhou Industrial Park, Suzhou, N/A, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Why was it recalled?
Potential of failing to trigger clinical scan during Bolus Tracking.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Device Identifier: (01)00884838085015, (01)00884838105508.
Distribution
U.S. Nationwide and U.S. Territories distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2988-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.