Z-1871-2024 Class II Ongoing
FDA device recall Z-1871-2024 was initiated by Philips North America Llc on Apr 15, 2024 and is designated Class II. Reason for recall: Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located… The recall status is ongoing. Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- Apr 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
Reason for Recall
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers- Applied to FCO72800819: 500046, 500064, 500074, 500102, 500110, 500111, 500145, 500168, 500178, 500211 500216, 500217, 500222, 500225, 500230, 500240, 500242. Serial Number-Applied to FCO72800820 : 500615
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1871-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026