Class 2 Device Recall Maxi Move Patient Lift with Scale

• Date Initiated by Firm: January 05, 2007
• Date Posted: May 11, 2007
• Recall Status: Terminated on September 02, 2008
• Recall Number: Z-0798-2007
• Recall Event ID: 37064
• Product Classification: Patient Lift - Product Code FSG
• Product: Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OLU2FUS
• Code Information: Model number KMBB4OLU2FUS, serial numbers SEE0624160, SEE0624161, SEE0624162, SEE0624163, SEE0624164, SEE0624165, SEE0624166, SEE0624167, SEE0624168, SEE0624169, SEE0624170, SEE0624171, SEE0624172, SEE0624173, SEE0624174, SEE0624175, SEE0624177, SEE0624178, SEE0624179, SEE0624180, SEE0624181, SEE0624182, SEE0624183, SEE0624184, SEE0624185, SEE0624186, SEE0624187, SEE0624188, SEE0624189, SEE0624190, SEE0624191, SEE0624192, SEE0624193, SEE0624194, SEE0624195, SEE0624196, SEE0624197, SEE0624198, SEE0624199, SEE0624200, SEE0624201, SEE0624202, SEE0624203, SEE0624204, SEE0624205, SEE0624206, SEE0624207, SEE0624208, SEE0624209, SEE0624210, SEE0624211, SEE0624212, SEE0624213, SEE0624214, SEE0624215, SEE0624216, SEE0624217, SEE0624218, SEE0624219, SEE0624220, SEE0624221, SEE0624222, SEE0624223, SEE0624224, SEE0624225, SEE0624226, SEE0624227, SEE0624228, SEE0624229,SEE0624230, SEE0624231, SEE0624233, SEE0624234, SEE0624235, SEE0624236, SEE0624237, SEE0624238, SEE0624239, SEE0624240, SEE0624567, SEE0624568,SEE0624569, SEE0624570, SEE0624571, SEE0624572, SEE0624573, SEE0624574, SEE0624575, SEE0624576, SEE0624577, SEE0624578, SEE0624579, SEE0624580, SEE0624581, SEE0624582, SEE0624583, SEE0624584, SEE0624585, SEE0624586, SEE0624587, SEE0624588, SEE0624589, SEE0624591, SEE0624592, SEE0624593,SEE0624594, SEE0624595, SEE0624596, SEE0624597, SEE0624598, SEE0624599, SEE0624600, SEE0624601, SEE0624602, SEE0624603, SEE0624604, SEE0624605,SEE0624606, SEE0624607, SEE0624608, SEE0624609, SEE0624610, SEE0624611, SEE0624612, SEE0624613, SEE0624614, SEE0624615, SEE0624616, SEE0624617,SEE0624618, SEE0624619, SEE0624621, SEE0624622, SEE0624623, SEE0624624, SEE0624625, SEE0624626, SEE0624628, SEE0624629, SEE0624630, SEE0624631,SEE0624632, SEE0624633, SEE0624634, SEE0624635, SEE0624636 (Manufactured week 24 of 2006 through week 28 of 2006. You can check the model and serial number of your unit by looking at the serial number label on the mast of the lift, located underneath the removable battery. Serial numbers are all structured SEEYYWWXXX, where ¿ YY = the last two digits of the year, ¿ WW = the two digits of the production week, and ¿ XXX = the sequential number the unit was in production that week ¿ Example: SEE06024001 = the first unit produced in week 24 of 2006. If your equipment has one of the model numbers listed above and a serial number beginning with SEE0624 through SEE0628, it is affected by this notification, regardless of the last three digits of the serial number.)
• Recalling Firm/ Manufacturer: Arjo, Inc.; 50 Gary Ave Ste A; Roselle IL 60172-1684
• For Additional Information Contact: Ms. Traci Giovenco; 800-323-1245
• Manufacturer 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 146 lifts
• Distribution: Nationwide

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.