Reported Mar 18, 2015 · Terminated

Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk…

Arjo Hospital Equipment AB

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Arjo Hospital Equipment AB · HANS MICHELSENSGATAN 10 · Malm¿, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.
Amount recalled
1,034 units

Where it was sold

  • Nationwide

Why it was recalled

The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 4, 2016 · Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.