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U.S. Department of Health and Human Services

Class 2 Device Recall Maxi Move Patient Lift with Scale

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  Class 2 Device Recall Maxi Move Patient Lift with Scale see related information
Date Initiated by Firm January 05, 2007
Date Posted May 11, 2007
Recall Status1 Terminated 3 on September 02, 2008
Recall Number Z-0796-2007
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 KMBB4ELU2FUS
Code Information Model number KMMB4ELU2FUS, serial numbers SEE0624509, SEE0624510, SEE0624511, SEE0624512, SEE0624513, SEE0624514, SEE0624515   (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 2		 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 7 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.
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