Arjo Pressure IQ Evolve Mattress Recalled for Pressure Ulcer Risk
Arjo is recalling 1,034 Pressure IQ Evolve mattresses nationwide due to failures that resulted in pressure ulcers.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reported injuries (pressure ulcers), which aligns with the rubric criteria for a Severe rating (Score 4) involving significant injury reports.
Plain-English summary
Arjo Hospital Equipment AB is recalling 1,034 units of the Pressure IQ Evolve Mattress, a non-powered mattress replacement system intended for patients with medium to high risk for developing pressure ulcers. The recall covers all mattresses equipped with 60g pods manufactured between January 2012 and December 2013. The products were distributed nationwide.
The recall was initiated after the firm received complaints that multiple mattresses were showing failures resulting in pressure ulcers. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and consumers who have these specific mattresses should stop using them immediately. Arjo Hospital Equipment AB is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
- Manufacturer
- Arjo Hospital Equipment AB
- Affected units
- 1,034
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 (2)
- All Pressure IQ Evolve mattresses equipped with the 60g pods
- manufactured January 2012-December 2013.
Distribution
Distributed nationwide across the United States.
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