CLASS II Device recall · Reported 18 Mar 2015 · FDA Enforcement Report

Pressure IQ Evolve Mattress recalled by Arjo Hospital Equipment AB

Arjo Hospital Equipment AB is recalling Pressure IQ Evolve Mattress, distributed nationwide in the US. The recall was initiated on 1 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.

Quantity recalled1,034 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1247-2015
FDA event ID: 68235
Recalling firm: Arjo Hospital Equipment AB, Malm¿, N/A
Classification: Class II
Status: Terminated
Recall initiated: 1 Sep 2014
FDA classified: 6 Mar 2015
Reported: 18 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 Sep 2014	Recall initiated by company
6 Mar 2015	Classified by FDA	+186 days
18 Mar 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is Pressure IQ Evolve Mattress recalled?

Yes. Arjo Hospital Equipment AB recalled Pressure IQ Evolve Mattress on 1 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-1247-2015.

Why was it recalled?

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

Which lots are affected?

All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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