ProxiDiagnost N90. radiography and fluoroscopy system
Enforcement
- Recall Number
- Z-1325-2022
- Event ID
- 90490
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips Medical Systems DMC GmbH
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- July 20, 2022
- Initiation Date
- May 19, 2021
- Classification Date
- July 12, 2022
- Address
- Development And Manufacturing Ctr., Rontgenstr. 24-26, Hamburg, N/A, Germany
Description
ProxiDiagnost N90. radiography and fluoroscopy system
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.
Model 706100 - Serial Number - 10001002 10001003 10001009 10001012 10001014 10001017 10001019 10001020 10001021 10001023 10001027 10001028 10001030 10001037 10001038 10001039 10001040 10001041 10001042 10001043 10001044 10001047 10001049 10001051 20000079 Model 706110 10001052 10001058 10001062 10001068 10001087 10001057 10001059 10001064
US Nationwide Distribution
140 systems in total, (Updated 1/30/2023).