Z-1563-2022 Class II Ongoing
FDA device recall Z-1563-2022 was initiated by Philips North America Llc on Feb 25, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 11 systems (updated 1/3/2023).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 7, 2022
- Initiation Date
- Feb 25, 2022
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 11 systems (updated 1/3/2023)
Product Description
DigitalDiagnost C50 1.1
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.
Distribution Pattern
Nationwide Distribution including Puerto Rico
Code Information
Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1563-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026