Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4ELU2FUS
FDA Recall Z-0796-2007 · Posted 2007-05-11
Recalling FirmArjo, Inc.
Recall StatusTerminated
Product CodeFSG
Date Initiated2007-01-05
Date Terminated2008-09-02
Product Quantity7 lifts
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.
Firm Action
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
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.