Philips recalls CombiDiagnost R90 X-ray systems with software versions 1.0.0-1.0.2 due to potential increased radiation exposure during patient scans. Affected units may require software update or repair.
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Philips is recalling certain CombiDiagnost R9:0 X-ray systems that may deliver higher radiation doses to patients because a key safety feature isn't working properly. This could lead to unnecessary radiation exposure during medical imaging procedures.
The kV/mA lockin feature, which helps control radiation dose during X-ray imaging, isn't functioning correctly in some units. This could allow the system to deliver higher radiation doses to patients than intended, potentially increasing their exposure risk.
Patients undergoing X-ray procedures at facilities using the recalled CombiDiagnost R90 systems with specific software versions are most at risk. Healthcare providers using these systems should check their equipment.
Check if your CombiDiagnost R90 X-ray system has software versions 1.0.0, 1.0.1, or 1.0.2. The recall applies to all units sold with these software versions.
Verify your system's software version by contacting your healthcare facility or checking the device's settings.
The recall indicates a potential risk of increased radiation exposure, but the hazard is not described as causing serious injury or death. Philips has not specified a remedy, so users should check their software version.
Your CombiDiagnost R90 system is affected if it has software versions 1.0.0, 1.0.1, or 1.0.2. Check with your healthcare facility for the software version.
Contact your healthcare facility to check the software version. If affected, Philips may provide a software update or repair, but no specific remedy is stated in the recall notice.
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-0612-2019 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-0612-2019 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.
