FDA-Device2022-07-20Class II

DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system

Philips Medical Systems DMC GmbH
Hazard

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.

Sold states
US Nationwide Distribution
Affected count
140 systems in total, (Updated 1/30/2023).
Manufactured in
Development And Manufacturing Ctr., Rontgenstr. 24-26, Hamburg, Germany
Products
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1327-2022

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