Philips recalls all Infa-Therm Transport Mattresses with reference number 989805616831 1015 due to FDA labeling changes needed for 510(k) clearance. No action is required as the devices are not yet legally sold.
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Philips is recalling all Infa-Therm Transport Mattresses with reference number 989805616831 1015 because they were sold without proper FDA labeling changes. This means the products are not legally compliant and should not be used until the labeling meets new regulatory requirements.
The devices were sold without the necessary FDA labeling updates required for 510(k) clearance. This means they do not meet current regulatory standards and could be legally non-compliant, though no immediate safety hazard is described.
All owners of the Infa-Therm Transport Mattress with reference number 989805616831 1015 are affected. The risk is highest for users who have purchased the product from the manufacturer.
Check for the reference number 989805616831 1015 on the Infa-Therm Transport Mattress. All units are impacted by this recall.
Look for the reference number 989805616831 1015 on the mattress to confirm it is affected.
No action is required as the devices are not yet legally sold. The recall is about regulatory compliance, not immediate safety risks.
The recall is due to FDA labeling changes needed for 510(k) clearance, not a safety hazard. No injuries or risks are described.
Check for the reference number 989805616831 1015 on the mattress. All units are impacted by this recall.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0505-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-0505-2022 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.
