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Z-1247-2015 Class II Terminated

Recalled by Arjo Hospital Equipment AB — Malm¿, N/A

FDA device recall Z-1247-2015 was initiated by Arjo Hospital Equipment AB on September 1, 2014 and is designated Class II. Reason for recall: The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers. The recall status is terminated (terminated January 4, 2016). Affected quantity: 1,034 units.

Recall Details

Product Type: Devices
Report Date: March 18, 2015
Initiation Date: September 1, 2014
Termination Date: January 4, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,034 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide Distribution.

Code Information

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

Other recalls by Arjo Hospital Equipment AB

Z-1217-2015 Class II — Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient (December 3, 2014)
Z-1218-2015 Class II — TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critica (December 3, 2014)
Z-1216-2015 Class II — RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic T (December 3, 2014)
Z-0019-2015 Class II — ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients we (March 17, 2014)