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Recall Observatory FDA recall evidence

Device product

Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the distribution of body weight for pressure relief. PositionPRO offers turn assist. PositionPRO is for use with GoBed II¿, Secure II/3¿, InTouch¿, and Epic II¿ 84 in. x 35 in. flat deck frames. This surface is powered via an AC power cord that comes in either a 4 foot long option (PN QDF8087) or 15 foot long option (PN QDF8088). The 4 foot long option is used when the surface is plugged into the auxiliary outlet of the bed. The 15 foot long option is utilized when the surface needs to be plugged into a wall outlet. This product uses a power cord, manufactured by ElectriCord that plugs into the wall outlet or the auxiliary outlet of the bed that the surface is placed onto.

Z-1081-2016

December 03, 2015

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 72935
Status
Terminated
Classification
Class II
Quantity
2694
Official record key
device-enforcement:Z-1081-2016

Official wording

Reason: Potential for power cord to melt; hazards include electric shock and fire.

Code information: model number: 2920-000-000 units serialized

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Chile, France, Hong Kong, Italy, Mexico, South Korea, Switzerland, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for power cord to melt; hazards include electric shock and fire.