Philips recalls DigitalDiagnost 4 Flex/Value radiography systems with specific serial numbers due to potential incorrect radiation dose from misaligned image fields after system restarts. Affected units may show wrong anatomy positioning during exams.
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 4 Flex/Value radiography systems because a firmware issue can cause incorrect radiation doses and misaligned anatomy markers during exams after system restarts. This could lead to improper radiation exposure and inaccurate imaging results.
The system's firmware issue causes the Wallstand VS2 board to rotate the amplimat field selection by 90 degrees after a restart. This misalignment can lead to incorrect radiation doses and mispositioned anatomical markers, potentially affecting the correct side of the body during exams.
Medical facilities using the recalled DigitalDiagnost 4 Flex/Value systems with specific serial numbers are most at risk. Patients undergoing exams on these systems may receive incorrect radiation doses.
Check if your system has serial numbers 10001088, 10001095, 10001097, 10001102, 10001104, 10001105, 10001112, or 19000317. The affected models are Philips DigitalDiagnost 4 Flex/Value radiography systems.
Verify your system's serial number against the list: 10001088, 10001095, 10001097, 10001102, 10001104, 10001105, 10001112, 19000317.
The recall is due to a firmware issue in the Wallstand VS2 board that causes the system to rotate the amplimat field selection by 90 degrees after a restart, potentially leading to incorrect radiation doses and misaligned anatomical markers.
Patients undergoing exams on affected systems may receive incorrect radiation doses and have anatomical markers mispositioned, potentially affecting the correct side of the body.
Check your system's serial number against the list: 10001088, 10001095, 10001097, 10001102, 10001104, 10001105, 10001112, or 19000317.
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-1327-2022 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-1327-2022 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.
