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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Position Pro

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  Class 2 Device Recall Stryker Position Pro see related information
Date Initiated by Firm December 03, 2015
Date Posted March 08, 2016
Recall Status1 Terminated 3 on May 24, 2017
Recall Number Z-1081-2016
Recall Event ID 72935
Product Classification Mattress, air flotation, alternating pressure - Product Code FNM
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.
Code Information model number: 2920-000-000 units serialized
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information Contact Stryker Customer Service
800-327-0770
Manufacturer Reason
for Recall		 Potential for power cord to melt; hazards include electric shock and fire.
FDA Determined
Cause 2		 Component design/selection
Action Stryker sent an URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letter dated November 10, 2015 to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Normal business hours are Monday-Friday 8 a.m-5 p.m. (ET).
Quantity in Commerce 2694
Distribution Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Chile, France, Hong Kong, Italy, Mexico, South Korea, Switzerland, United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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