Philips North America Llc: Medical Device Recall in 2022 - (Recall #: Z-1563-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

DigitalDiagnost C50 1.1

Product Classification:

Class II

Date Initiated: February 25, 2022

Date Posted: September 7, 2022

Recall Number: Z-1563-2022

Event ID: 90728

Reason for Recall:

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 the 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. (Added 1/3/2023), 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.

Status: Ongoing

Product Quantity: 11 systems (updated 1/3/2023)

Code Information:

Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020

Distribution Pattern:

Nationwide Distribution including Puerto Rico

Voluntary or Mandated:

FDA Mandated