Recall Z-1081-2016 ยท FNM Mattress, Air Flotation, Alternating Pressure
Stryker Medical Division of Stryker Corporation
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. PositionP
| Date | Mar 8, 2016 (initiated Dec 3, 2015) |
| Status | Terminated |
| Reason | Potential for power cord to melt; hazards include electric shock and fire. |
| Root cause | 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 | 2694 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Chile, France, Hong Kong, Italy, Mexico, South Korea, Switzerland, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.