Philips recalls CombiDiagnost R90 software versions R1.0 and R1.1 due to potential image exposure issues. Affected units may produce over or under exposed images.
Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
Philips is recalling CombiDiagnost R90 software versions R1.0 and R1.1 because a software issue can cause images to be over or under exposed. This could lead to inaccurate medical imaging results.
The software issue causes kV and mA values to change when the collimator shutter is moved after a Lock-In command. This can result in images being over or under exposed, potentially leading to inaccurate medical imaging results.
Medical professionals using the CombiDiagnost R90 system with affected software versions. Those who rely on accurate imaging results are most at risk.
Check if your CombiDiagnost R90 system has software version R1.0 or R1.1. The model number is 706100.
Verify your CombiDiagnost R90 software version is R1.0 or R1.1.
The software issue can cause images to be over or under exposed, potentially leading to inaccurate medical imaging results.
Check your software version; if it's R1.0 or R1.1, contact Philips for a software update.
No, the hazard does not involve physical injury but potential inaccurate imaging results.
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-2357-2021 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-2357-2021 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.
