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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1326-2022

DigitalDiagnost 4 High Performance. radiography and fluoroscopy system

Publicado el 20 de julio de 2022 · Inicio del retiro: 19 de mayo de 2021

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

FDA Mandated · Letter

Detalles del retiro

Fabricante
Philips Medical Systems DMC GmbH
Distribuidor
US Nationwide Distribution
Lote
Model 712031 Serial Numbers - 10001009 10001111 18000123 19000181 20010235 10001039 17000264 18000263 19000297
Clasificación de riesgo
Class II
Área (FDA)
device
País
Germany

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