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U.S. Department of Health and Human Services

Class 2 Device Recall Arjo Maxi 500

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  Class 2 Device Recall Arjo Maxi 500 see related information
Date Initiated by Firm October 20, 2008
Date Posted November 24, 2008
Recall Status1 Terminated 3 on August 19, 2010
Recall Number Z-0322-2009
Recall Event ID 50079
Product Classification Non-Ac-Powered Patient Lift - Product Code FSA
Product Arjo Maxi 500 Patient Lift with 2 Point Spreader Bar and Scale; a Non-AC-Powered Patient Lift; Model KM560101; BHM Medical Inc., Magog, QC, Canada

The Maxi 500 is a mobile passive lift intended to be for lifting and transferring of patients in hospitals, nursing homes, or other health care facilities.
Code Information serial numbers KM5610713, KM5610729, KM5610737, KM5610114, KM5610115, KM5610550, KM5610711, KM5610551, KM5610693, KM5610694, KM5610696, KM5611003, KM5611004, KM5611005, KM5611006, KM5611007, KM5611008, KM5611009, KM5611010, KM5611011, KM5611012, KM5611013, KM5611014, KM5611015, KM5611016, KM5611017, KM5611018, KM5611019, KM5611020, KM5611021, KM5611022, KM5611023, KM5611024, KM5611025, KM5611026, KM5611027, KM5610813, and KM5610667.
Recalling Firm/
Manufacturer		 Arjo, Inc.
50 Gary Ave
Roselle IL 60172-1605
For Additional Information Contact Ms. Traci Giovenco
800-323-1245 Ext. 6125
Manufacturer Reason
for Recall		 The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the hanger bar falling.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Arjo sent an Urgent Device Recall Customer Notification letter dated 10/20/08 to all affected end users to the attention of the Administrator/Risk Manager via UPS 2nd day on the 10/20/08. The letters informed the accounts of the potential for the hanger bar to detach from the scale due to shearing of the pivot bolt. The accounts were advised to review the enclosed Safety Advisory Notice, note the affected model and serial numbers, and avoid using the lift under load on a high friction floor like carpet or soft tile while using the hanger bar to move the lift. The accounts were advised that an Arjo Field Service Technician would contact them within two weeks to schedule a visit to the account to perform repairs on their Maxi 500 lifts. Any questions were directed to Arjo Quality Department at 800-323-1245, ext. 6118. The accounts were also instructed to complete and fax back to Arjo the enclosed Customer Response Form, providing the facility name and address, contact name and phone number, the numbers of affected units, and acknowledgment of receipt and understanding of the Urgent Device Correction.
Quantity in Commerce 38 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
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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