Z-1329-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 20, 2022
- Initiation Date
- May 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 140 systems in total, (Updated 1/30/2023).
Product Description
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Model 712035 Serial Numbers 21862105 21862107 21862123 21862126 22860027