Product Wiki · Recalls · Health Canada — Marketed Health Products

FL14E Rose Bed - Risk of Bed Siderail Collapse - Notice to Hospitals — recall 49221

Health Canada — Marketed Health Products · Canada · 2013-05-07

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Agency
Health Canada — Marketed Health Products
Recall identifier
49221
Date of alert
2013-05-07
Country / jurisdiction
Canada
Risk type
recall
Product category
Medical devices
Product type
Marketed health products
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Dear Risk Management/Biomedical engineering and Health Professionals, Stryker Canada, in collaboration with Health Canada, is providing this Notice to inform you on the risk of siderail collapse with the hospital bed - FL14E Rose Bed. It was reported that the siderail may appear latched in the upright position when it is not fully locked in place and may unexpectedly collapse if a pressure is applied on it. This failure has resulted in bruises and/or lacerations to patients who are leaning against the siderail when it collapses. Additionally, the siderail may not effectively prevent a patient from rolling or falling off the bed. Seven incidents, including three cases resulting in injuries to patients, were reported in Canada.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/fl14e-rose-bed-risk-bed-sidera

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