Philips recalls ProxiDiagnost N90 R.1.0 devices missing FDA certification labels. Affected units may not meet regulatory standards. Consumers should check serial numbers listed in the recall notice.
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 specific models of ProxiDiagnost N90 R.1.0 devices that lack an FDA certification label. This issue means the devices might not meet regulatory standards, but it does not pose a direct safety risk to users.
The devices are missing a required FDA certification label, which means they may not meet regulatory standards. However, this is a compliance issue rather than a safety hazard that could cause injury or damage.
Owners of the ProxiDiagnost N90 R.1.0 devices with the listed serial numbers are affected. These devices were sold in the U.S. market.
Check if your device has a serial number listed in the recall notice: 10001015, 10001019, 10001020, 10001021, 10001022, 10001023, 10001026, 10001027, 10001028, 10001030, 10001033, 10001036, 10001037, 10001038, 10001039, 10001040, 10001042, 10001051, or 20000067.
Look for the serial number on your device to see if it matches the list provided in the recall notice.
Philips identified that these devices are missing a required FDA certification label, which means they may not meet regulatory standards.
No, this is a compliance issue with regulatory labeling, not a safety hazard that could cause injury.
Check the serial number on your device against the list: 10001015, 10001019, 10001020, 10001021, 10001022, 10001023, 10001026, 10001027, 10001028, 10001030, 10001033, 10001036, 10001037, 10001038, 10001039, 10001040, 10001042, 10001051, or 20000067.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1587-2023 — Philips Philips Hello, I own a Philips that is covered by recall Z-1587-2023 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.
