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.
This recall has been terminated (originally issued March 6, 2015).
- Recall Initiated
- September 1, 2014
- Posted
- March 6, 2015
- Terminated
- January 4, 2016
- Recall Number
- Z-1247-2015
- Quantity
- 1,034 units
- Official Source
- View on FDA website ↗
Reason for Recall
The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
Distribution
Nationwide Distribution.
Lot / Code Info
All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.
Root Cause
Device Design
Action Taken
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.
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