Philips recalls ProxiDiagnost N90 radiography systems with serial numbers 10001002-10001064. Incorrect radiation dose and misaligned anatomy markers may occur due to firmware issues after system restarts.
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 ProxiDiagnost N90 radiography systems that may show incorrect radiation doses and misaligned anatomy markers after a system restart. This could lead to improper radiation exposure during medical imaging procedures.
After a system restart where the Wallstand VS2 is set to default, the system may rotate the amplimat field selection by 90 degrees. This causes incorrect radiation doses and mispositioned anatomy markers, potentially exposing patients to improper radiation levels.
Healthcare facilities using Philips ProxiDiagnost N90 systems with specific serial numbers are affected. Medical staff performing radiography or fluoroscopy procedures are most at risk of incorrect radiation exposure.
Check for serial numbers listed in the recall: 10001002 through 10001064. The affected models are Philips ProxiDiagnost N90 radiography and fluoroscopy systems with these specific serial numbers.
Identify the serial number on your ProxiDiagnost N90 system to confirm if it's in the recall list (10001002-10001064).
Reach out to Philips for guidance on next steps if your system is affected by the recall.
The recall occurs because firmware issues in the Wallstand VS2 board cause incorrect radiation doses and misaligned anatomy markers after system restarts.
Check if your ProxiDiagnost N90 system has a serial number between 10001002 and 10001064.
Contact Philips for guidance on next steps; the recall does not include a specific fix or replacement.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1325-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-1325-2022 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.
