PlainRecalls
FDA Devices Moderate Class II Ongoing

DigitalDiagnost C50 1.1

Reported: September 7, 2022 Initiated: February 25, 2022 #Z-1563-2022

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.

Details

Recalling Firm
Philips North America Llc
Units Affected
11 systems (updated 1/3/2023)
Distribution
Nationwide Distribution including Puerto Rico
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
DigitalDiagnost C50 1.1. Recalled by Philips North America Llc. Units affected: 11 systems (updated 1/3/2023).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1563-2022.