FDA Medical Device Recalls (openFDA)
Arjo Hospital Equipment AB: 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.
- Recall number
- Z-1247-2015
- Recalling firm
- Arjo Hospital Equipment 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.
- Status
- Terminated
- Initiated
- 2014-09-01
- Posted
- 2015-03-06
- Terminated
- 2016-01-04
- Reason
- The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
- 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
- 1,034 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IKY
- Firm FEI
- 3002806395
- Firm city
- Malm¿
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28