Philips recalls DigitalDiagnost C90 radiography systems with serial numbers starting 10001073-10001201 and others. Incorrect radiation dose and image orientation may occur after system restarts using Wallstand VS2, requiring immediate attention.
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 certain DigitalDiagnost C90 radiography systems due to a firmware issue that can cause incorrect radiation doses and misaligned anatomical markers after system restarts. This could lead to improper imaging and potential radiation exposure risks during medical procedures.
After a system restart following a Wallstand VS2 switch, the system may rotate the amplimat field selection by 90 degrees. This causes incorrect radiation doses and mispositioned anatomical markers, potentially leading to imaging errors and radiation exposure risks during procedures.
Healthcare facilities using Philips DigitalDiagnost C90 systems with specific serial numbers are affected. Medical staff performing radiography or fluoroscopy procedures are most at risk of incorrect radiation doses and misaligned anatomical markers.
Check for serial numbers listed in the recall: 10001073, 10001104, 10001108, and others up to 22860118. The affected systems are Philips DigitalDiagnost C90 High Performance radiography and fluoroscopy systems.
Verify your system's serial number against the list provided in the recall notice to confirm if it is affected.
Ensure the Wallstand VS2 is not switched to during system restarts to prevent incorrect image orientation and radiation dosing.
The recalled system is Philips DigitalDiagnost C90 High Performance radiography and fluoroscopy system with specific serial numbers listed in the recall notice.
The issue can cause incorrect radiation doses and misaligned anatomical markers, potentially leading to imaging errors and increased radiation exposure risks during procedures.
The recall notice does not specify a fix; users must check their system settings and serial numbers to avoid the issue.
We’ve drafted a message you can send Philips Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1328-2022 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-1328-2022 from Philips Medical Systems. 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.