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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