Recall -- Firm Press Release
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Medibo N.V. Announces a Nationwide, Voluntary Recall of the MINERVA Patient Lifts
Minerva Recall Department
FOR IMMEDIATE RELEASE -- August 6, 2004 -- Medibo N.V. today announced that it is voluntarily conducting a Class I recall for 64 units of its MINERVA Patient Lifts (model numbers ML20 and ML30), because of mechanical problems that could result in serious patient injury. The FDA defines a Class I recall as a situation in which there is reasonable probability that the use of the product will cause serious adverse health consequences or death.
Medibo N.V. is aware of reports of the hanger bar falling off a similar product called the MINSTREL Lift, which caused the patient to fall and be injured. One of these incidents resulted in death. Since the MINERVA Patient Lift is similar to the MINSTREL lift in design and construction, Medibo N.V. deem it necessary to carry out the same field correction/recall procedure as for the Minstrel Lift.
This recall involves 64 MINERVA Patient Lifts that could possibly result in hanger bar detachment due to pin migration or pin breakage in the hanger bar assembly. No other Medibo N.V. devices are involved in this action.
All affected customers will be formally notified via certified mail of the MINERVA Field Correction/Recall by August 6, 2004 . Affected customers will have the option of inspecting their MINERVA Patient Lift and completing an Inspection Record or removing their MINERVA Patient Lift from use pending repair from an authorized Service Technician. All affected customers will be required to complete a Customer Response Form and return it to the Minerva Recall Department.
Medibo N.V. is voluntarily cooperating with the Food and Drug Administration to ensure that all affected customers are notified of this issue. Medibo N.V. formally notified the Food and Drug Administration on July 23, 2004.
Any inquiries regarding this action should be directed to the Minerva Recall Department using the above referenced toll-free number.