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Terminated

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.

FDA Recall Z-1247-2015 · Posted 2015-03-06

Recalling FirmArjo Hospital Equipment AB
Recall StatusTerminated
Product CodeIKY
Date Initiated2014-09-01
Date Terminated2016-01-04
Product Quantity1,034 units

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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