Z-2988-2026 Class II Ongoing
FDA device recall Z-2988-2026 was initiated by Philips Healthcare (Suzhou) Co., Ltd. on June 26, 2026 and is designated Class II. Reason for recall: Potential of failing to trigger clinical scan during Bolus Tracking. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- June 26, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- N/A
Product Description
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Reason for Recall
Potential of failing to trigger clinical scan during Bolus Tracking.
Distribution Pattern
U.S. Nationwide and U.S. Territories distribution.
Code Information
Device Identifier: (01)00884838085015, (01)00884838105508.