Medical Device Mattress Recalled for Labeling Non-Compliance with FDA Requirements
Philips is recalling 141,750 Infa-Therm Transport Mattresses because modified labeling does not comply with FDA clearance requirements. The devices cannot be distributed or sold without new FDA clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving labeling modifications that fall outside the scope of original clearance. No illnesses, injuries, or adverse events are reported. The hazard is regulatory and documentation-based rather than product-hazard-based.
Plain-English summary
Philips North America LLC is recalling the Infa-Therm Transport Mattress (Reference Number 989805616831 1015). The recall affects approximately 141,750 units distributed throughout the United States and Canada.
After the FDA originally cleared this medical device, Philips modified the product labeling. These labeling changes do not conform to the parameters of the original FDA clearance. According to FDA requirements, devices with non-conforming labeling cannot be distributed or sold without obtaining new 510(k) clearance.
Healthcare facilities and customers who have received this product should contact Philips for instructions regarding the affected units.
The recalled product
- Product
- Infa-Therm Transport Mattress, Reference Number 989805616831 1015
- Manufacturer
- Philips North America Llc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units are impacted
Distribution
Distributed nationwide across the United States.
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