Philips Medical Systems DMC GmbH: Medical Device Recall in 2022 - (Recall #: Z-1326-2022)

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 4 High Performance. radiography and fluoroscopy system

Product Classification:

Class II

Date Initiated: May 19, 2021

Date Posted: July 20, 2022

Recall Number: Z-1326-2022

Event ID: 90490

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 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.

Status: Ongoing

Product Quantity: 140 systems in total, (Updated 1/30/2023).

Code Information:

Model 712031 Serial Numbers - 10001009 10001111 18000123 19000181 20010235 10001039 17000264 18000263 19000297

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated