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Philips Medical Systems DMC GmbH devices, product family

by Philips Medical Systems DMC GmbH 7 variants Basic UDI-DI 0884838BM440SS

Shared by every variant

Basic UDI-DI
0884838BM440SS
Risk class
Class IIb
Legislation
MDR
Market status
7 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 0884838BM440SS.

Recalls

17 recalls · 17 ongoing · FDA

  • Z-2354-2026 Class II · ongoing · 1 May 2026
    System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
  • Z-0466-2026 Class II · ongoing · 1 Oct 2025
    Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
  • Z-0465-2026 Class II · ongoing · 1 Oct 2025
    Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
  • Z-0464-2026 Class II · ongoing · 1 Oct 2025
    Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
  • Z-0274-2024 Class II · ongoing · 21 Sep 2023
    Potential for units suspended on the ceiling to fail and fall.
  • Z-0277-2024 Class II · ongoing · 21 Sep 2023
    Potential for units suspended on the ceiling to fail and fall.
  • Z-0275-2024 Class II · ongoing · 21 Sep 2023
    Potential for units suspended on the ceiling to fail and fall.
  • Z-0272-2024 Class II · ongoing · 21 Sep 2023
    Potential for units suspended on the ceiling to fail and fall.
  • Z-0273-2024 Class II · ongoing · 21 Sep 2023
    Potential for units suspended on the ceiling to fail and fall.
  • Z-0278-2024 Class II · ongoing · 21 Sep 2023
    Potential for units suspended on the ceiling to fail and fall.
  • Z-0276-2024 Class II · ongoing · 21 Sep 2023
    Potential for units suspended on the ceiling to fail and fall.
  • Z-2042-2023 Class II · ongoing · 19 May 2023
    There is a software login in issue that may prevent the user from logging in.
  • Z-0239-2022 Class II · ongoing · 22 Sep 2021
    The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
  • Z-1326-2022 Class II · ongoing · 19 May 2021
    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.
  • Z-1328-2022 Class II · ongoing · 19 May 2021
    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.
  • Z-1329-2022 Class II · ongoing · 19 May 2021
    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.
  • Z-1327-2022 Class II · ongoing · 19 May 2021
    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.

Recalls matched to the 7 devices listed on this page; other pages of the family can carry others.

Variants

7 devices · page 1 of 1

Variants of Philips Medical Systems DMC GmbH devices, Basic UDI-DI 0884838BM440SS
UDI-DISize and differences
DigitalDiagnost 4 Chest / Emergency 71203300884838074521 —On the market
DigitalDiagnost 4 Flex / Value 71203200884838074514 —On the market
DigitalDiagnost 4 High Performance 71203100884838065321 —On the market
DigitalDiagnost C90 71203400884838090699 —On the market
DigitalDiagnost C90 71203500884838090705 —On the market
Radiography 7300 C 71203700884838116016 —On the market
SmartDiagnost 71203800884838132979 —On the market