DigitalDiagnost C50 1.1

FDA device recall Z-1563-2022 · posted 2022-09-01 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

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.

Action taken

Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated July 12, 2022. Philips will schedule an appointment with customers to install the software update at no cost to customers. For questions contact Philips Customer Care Solutions Center 1-800-722-9377.

Root cause

Software Design Change

Status

Open, Classified

Product code

KPR

Quantity affected

11 systems (updated 1/3/2023)

Distribution

Nationwide Distribution including Puerto Rico

Date initiated

2022-02-25

Date posted

2022-09-01

Location

Cambridge, MA

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