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FDA > CDRH > Medical Device Recalls > Class I Recall - Medibo Minerva Patient Lifts

Medical Device Recalls
Class I Recall: Medibo Minerva Patient Lifts

Date Recall
Initiated

August 4, 2004

(This patient lift is technically identical to Arjo’s Minstrel patient lift in which a recall was also initiated on 4/30/04.)
Product:
 Minerva Patient Lifts, models ML-20 (49 units) and ML-30 (15 units)
Use:
 The device is a battery powered patient lift. Patient lifts are intended to be used to lift and transport patients from one location to another, such as from a bed to a bath.
Recalling Firm:
 Medibo, N.V.,
Heikant 5,
Hanmont, Achel; Belgium
Reason for Recall:
 There are three mechanical problems for which the Minerva patient lift is currently being recalled. The first involves the hanger bar detaching from the lift resulting in the patient falling to the ground because of a missing spring washer. The second problem involves a bolt in the foot pedal assembly becoming loose which allows the foot pedal assembly to fall off of the lift. This results in the lift becoming unstable and the patient possibly falling. Thirdly, some units may have faulty actuator brackets on the mast assembly that can also cause the lift to become unstable.
Public Contact:
 Ms. Brenda Ammonette
Quality Assurance Manager
888-402-6448
FDA District:
 Chicago
FDA Comment:
 Facilities should follow the instructions in the Customer Advisory Notice sent to all end users or they should take the lifts out of service until they can be inspected by an authorized service engineer. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.
 

For additional information on this product recall, see the Medibo N.V. Press Release.

Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00864.html. Scroll down to "Recalls and Field Corrections: Devices - Class I".

Updated September 24, 2004

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