ClearanceBrief
Recall Z-0798-2007 ยท FSG

Arjo, Inc.

Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OLU2FUS

DateMay 11, 2007 (initiated Jan 5, 2007)
StatusTerminated
ReasonThe 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.
Root causeOther
ActionArjo 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
Quantity146 lifts
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.