Philips recalls DigitalDiagnost 4 High Performance radiography systems with incorrect radiation dose risk after system restarts. Affected units may show wrong image orientation and misaligned anatomical markers.
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 High Performance radiography systems because a firmware issue can cause incorrect radiation doses and misaligned anatomical markers during imaging. This could lead to improper treatment or unnecessary radiation exposure.
The system's firmware error causes the image orientation to flip 90 degrees after a restart when using Wallstand VS2. This misalignment can lead to incorrect radiation dosing and anatomical marker placement, potentially causing improper treatment.
Healthcare providers using the affected Philips DigitalDiagnost 4 systems are most at risk. Patients undergoing imaging with these systems may receive incorrect radiation doses.
Check for the model number 712031 on the system. Affected units were sold with serial numbers: 10001009, 10001111, 18000123, 19000181, 20010235, 10001039, 17000264, 18000263, 19000297.
Verify if the Wallstand VS2 is the default setting after a system restart.
Contact Philips for firmware updates to correct the issue.
The affected model is 712031 with specific serial numbers: 10001009, 10001111, 18000123, 19000181, 20010235, 10001039, 17000264, 18000263, 19000297.
Incorrect radiation dosing and misaligned anatomical markers could lead to improper treatment or unnecessary radiation exposure.
Yes, Philips offers firmware updates to correct 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-1326-2022 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-1326-2022 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.
