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Recall Observatory FDA recall evidence

Device product

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Z-0306-2024

October 09, 2023

Class II

Product summary

Firm
Philips North America
Event
Event 93363
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0306-2024

Official wording

Reason: 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.

Code information: UDI-DI: 00884838103627; Lot Code: 1005

Distribution pattern: US Nationwide distribution in the state of MN.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software crash. This would result in