Z-1247-2015Class II

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

Name: Z-1247-2015 Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to...
Creator: Arjo Hospital Equipment AB
Published: 2014-09-01
License: https://open.fda.gov/license/

Arjohuntleigh AB / initiated 2014-09-01 / Terminated / root cause: design

FDA source

Arjo Hospital Equipment AB began a recall of Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a... on 2014-09-01. FDA classified it as Class II and gives the reason as "The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1247-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-01
Posted: 2015-03-06
Terminated: 2016-01-04
Recalling firm: Arjohuntleigh AB
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.
Product code: IKY Mattress, Flotation Therapy, Non-Powered
Reason for recall: The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
Root cause tag: design
FDA root cause: Device Design
Action: On 9/1/14 the recalling firm sent out a letter to their customers notifying them of an updated IFU for the recalled device. The letter also requested the customers to verify the quantity of the product they currently have on hand.
Quantity in commerce: 1,034 units
Distribution: Nationwide Distribution.
Product codes and lots: All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1247-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1247-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06

Product code IKY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)