Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4ELU2FUS

FDA device recall Z-0796-2007 · posted 2007-05-11 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place.

Action taken

Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/5/07 to the end user accounts who received the affected lifts, advising them of the potential for the hanger bar assembly to detach. They were informed that an Arjo Field Service Technician would call them within five business days to schedule the time for him to visit and perform the inspection and correction to the lifts involved. If they did not hear from the technician within that time, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140. The accounts were also requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter.

Root cause

Other

Status

Terminated

Product code

FSG

Quantity affected

7 lifts

Distribution

Nationwide

Date initiated

2007-01-05

Date posted

2007-05-11

Date terminated

2008-09-02

Location

Roselle, IL