ProxiDiagnost N90. radiography and fluoroscopy system

FDA device recall Z-1325-2022 · posted 2022-07-12 · Open, Classified

Recall details

Recalling firm

Philips Medical Systems DMC GmbH

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.

Action taken

Philips sent an Electronic Product Radiation Defect notification letter dated May 25, 2022 to affected customers. Philips will schedule an appointment with customers to install the software update. Philips will, without charge bring the product into compliance. Customers were instructed to complete and return the attached response form to Philips. For further information or support concerning this issue, please contact Philips Customer Care Solutions Center: 1-800-722-9377 and reference FCO71200223 for impacted DigitalDiagnost systems or FCO70600109 for impacted ProxiDiagnost systems.

Root cause

Radiation Control for Health and Safety Act

Status

Open, Classified

Product code

JAA

Quantity affected

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

Distribution

US Nationwide Distribution

Date initiated

2021-05-19

Date posted

2022-07-12

Location

Hamburg, Germany

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