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Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

Country not established FDA establishment FEI 3011676026

Devices
0
Registrations
FDA
FDA recalls
2

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
3011676026
Address
Bradninch Hall, Castle Street, Exeter Devon

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 2
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2021

    • 4 Jun 2021 Z-2253-2021 Class II Terminated A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data Distribution: US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia Submission number: K142779
    • 4 Jun 2021 Z-2254-2021 Class II Terminated A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data Distribution: US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia Submission number: K142779

This is an FDA establishment record without devices in deviCERTS.