Philips recalls CombiDiagnost R90 R1.1 devices missing FDA certification labels. Affected units have specific serial numbers; owners should 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 R1.1 devices that lack a required FDA certification label. This issue does not pose a safety risk but violates regulatory compliance.
The devices are missing an FDA certification label required by law. This means they do not meet regulatory standards for medical equipment, but it does not cause physical harm or injury during normal use.
Owners of CombiDiagnost R90 R1.1 devices with specific serial numbers (10001071, 10001072, 10001086, 10001087, 10001114) are affected. Medical professionals using these devices may be at risk if they rely on the certification for regulatory compliance.
Check for the serial numbers 10001071, 10001072, 10001086, 10001087, or 10001114 on the CombiDiagnost R90 R1.1 device. The product was sold by Philips North America.
Look for the missing FDA certification label on the device.
Philips identified that these devices lack a required FDA certification label, which is a compliance issue.
Contact Philips directly for instructions on how to proceed with the affected units.
No, the missing label does not cause physical harm but violates regulatory compliance.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1589-2023 — Philips Philips Hello, I own a Philips that is covered by recall Z-1589-2023 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.
