Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB0

FDA device recall Z-0883-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Arjo, Inc.

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.

Action taken

All 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.

Root cause

Other

Status

Terminated

Product code

FSA

Quantity affected

46 units

Distribution

Nationwide. District of Columbia, New York, Washington, Iowa, Florida, North Carolina, Louisiana, Virginia, South Carolina, Minnesota and Colorado

Date initiated

2003-01-30

Date posted

2004-07-20

Date terminated

2004-05-12

Location

Roselle, IL