Philips recalls DigitalDiagnost C50 1.1 models due to potential incorrect radiation dose from misaligned imaging. Affected units may show wrong anatomy positions during scans.
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.
Philips recalls specific DigitalDiagnost C50 1.1 models because firmware issues can cause incorrect radiation doses and misaligned anatomical markers during scans. This could lead to improper radiation exposure and inaccurate imaging results.
The system's firmware issue causes it to rotate the amplimat field selection by 90 degrees after certain operations. This misalignment can lead to incorrect radiation doses and misplaced anatomical markers, potentially affecting scan accuracy and patient safety.
Medical professionals using Philips DigitalDiagnost C50 1.1 imaging systems with specific model numbers are affected. Patients receiving scans on these systems may be at risk of incorrect radiation exposure.
Check for model number 712204 or serial numbers listed in the recall notice (210182, 210187, 220002, 210049, 210051, 210097, 210052, 210053, 210055, 220020).
Verify your DigitalDiagnost C50 1.1 has model number 712204 or one of the listed serial numbers.
The system may rotate the amplimat field selection by 90 degrees after certain operations, causing incorrect radiation doses and misaligned anatomical markers during scans.
Check for model number 712204 or serial numbers listed in the recall notice (210182, 210187, 220002, 210049, 210051, 210097, 210052, 210053, 210055, 220020).
No action is required for units not listed in the recall notice.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1563-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-1563-2022 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.
