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Recall Observatory FDA recall evidence

Device product

DigitalDiagnost C50 1.1

Z-1563-2022

February 25, 2022

Class II

Product summary

Firm
Philips North America Llc
Event
Event 90728
Status
Ongoing
Classification
Class II
Quantity
11 systems (updated 1/3/2023)
Official record key
device-enforcement:Z-1563-2022

Official wording

Reason: Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Added 1/3/2023), Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

Code information: Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020

Distribution pattern: Nationwide Distribution including Puerto Rico

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    issue in the firmware