Z-0306-2024 Class II Ongoing
FDA device recall Z-0306-2024 was initiated by Philips North America on October 9, 2023 and is designated Class II. Reason for recall: When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2023
- Initiation Date
- October 9, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Reason for Recall
When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
Distribution Pattern
US Nationwide distribution in the state of MN.
Code Information
UDI-DI: 00884838103627; Lot Code: 1005