Philips recalls CombiDiagnost R90 R.1.0 devices missing FDA certification labels. Owners should check serial numbers and contact Philips for details.
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
Philips is recalling CombiDiagnost R90 R.1.0 devices that lack an FDA certification label. This issue means the devices may not meet safety standards, but it does not pose an immediate risk of injury.
The devices are missing an FDA certification label, which is required for medical devices to meet safety standards. This could mean the devices do not meet regulatory requirements, but it does not indicate an immediate risk of injury or malfunction.
Users of the CombiDiagnost R90 R.1.0 devices with serial number 10001076 are affected. Healthcare professionals using these devices for medical diagnostics are most at risk.
Check for the serial number 10001076 on the device. The affected models are CombiDiagnost R90 R.1.0 with the reference number 709030.
Look for the FDA certification label on the device. If missing, it is part of the recall.
Philips has identified that these devices are missing an FDA certification label, which is required by law for medical devices.
Check for the serial number 10001076 and reference number 709030 on the CombiDiagnost R90 R.1.0 device.
Contact Philips directly to confirm if your device is affected and follow their instructions.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1588-2023 — Philips Philips Hello, I own a Philips that is covered by recall Z-1588-2023 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.
