Philips recalls DigitalDiagnost C90 radiography systems due to incorrect radiation dose and image orientation risks after system restarts with Wallstand VS2. Affected units may require correction to prevent misdiagnosis.
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.
Philips is recalling DigitalDiagnost C90 radiography systems because a firmware issue can cause incorrect radiation doses and misaligned images after certain system restarts. This could lead to improper medical diagnoses if not corrected.
The system's Wallstand VS2 board has a firmware issue that causes it to rotate the amplimat field selection by 90 degrees after a restart. This can lead to incorrect radiation doses and mispositioned anatomical markers, potentially causing misdiagnosis.
Healthcare professionals using Philips DigitalDiagnost C90 systems with specific serial numbers are affected. Patients receiving scans on these systems may be at risk of incorrect radiation doses.
Check for the model number 712035 and serial numbers 21862105, 21862107, 21862123, 21862126, or 22860027 on the system. These units were sold between 2020 and 2023.
Verify if the system has been restarted after using Wallstand VS2 and if the image orientation appears incorrect.
Reach out to Philips for guidance on correcting the issue or obtaining a firmware update.
The system may deliver incorrect radiation doses and misposition anatomical markers, potentially leading to misdiagnosis.
Check for the model number 712035 and serial numbers 21862105, 21862107, 21862123, 21862126, or 22860027 on your system.
Philips provides guidance on correcting the issue through system settings or by contacting their support team.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1329-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-1329-2022 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
