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U.S. Department of Health and Human Services

Class 2 Device Recall Minstrel Patient Lift

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 Class 2 Device Recall Minstrel Patient Liftsee related information
Date Initiated by FirmJanuary 30, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on May 12, 2004
Recall NumberZ-0883-04
Recall Event ID 28866
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
ProductMinstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)
Code Information model numbers HMB001-US and HMB002-US, all units with and without scales up to and including serial number MPLA0203A0464
Recalling Firm/
Manufacturer		 Arjo, Inc.
50 Gary Ave Ste A
Roselle IL 60172-1684
For Additional Information ContactMs. Brenda Ammonette
800-323-1245
Manufacturer Reason
for Recall		The tension pin was not installed in spreader bar pivot bolt to prevent the pivot bolt from migrating out of the spreader bar, allowing the spreader bar to detach from the lift.
FDA Determined
Cause 2		Other
ActionAll affected end users were given a copy of the Customer Advisory Notice dated 1/30/03, during the Arjo salesmen visits to inspect the Minstrel lifts for the presence of the tension pin in the pivot bolt of the lift. The advisory informed the user of the incident where the spreader bar detached from the scale unit. The end user was requested to read the advisory and sign the bottom portion of it certifying that they read the advisory and that the Arjo salesman inspected their units for the presence of the tension pin, retaining a copy of the signed advisory notice and the inspeciton record.
Quantity in Commerce46 units
DistributionNationwide. District of Columbia, New York, Washington, Iowa, Florida, North Carolina, Louisiana, Virginia, South Carolina, Minnesota and Colorado
Total Product Life CycleTPLC 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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