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Recall Observatory FDA recall evidence

Device product

DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system

Z-1329-2022

May 19, 2021

Class II

Product summary

Firm
Philips Medical Systems DMC GmbH
Event
Event 90490
Status
Ongoing
Classification
Class II
Quantity
140 systems in total, (Updated 1/30/2023).
Official record key
device-enforcement:Z-1329-2022

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 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. (Updated 1/30/23) 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 712035 Serial Numbers 21862105 21862107 21862123 21862126 22860027

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    issue in the firmware