Z-0322-2009

Arjo Maxi 500 Patient Lift with 2 Point Spreader Bar and Scale; a Non-AC-Powered Patient Lift; Model...

Name: Z-0322-2009 Arjo Maxi 500 Patient Lift with 2 Point Spreader Bar and Scale; a Non-AC-Powered Patient Lift; Model...
Creator: Arjo, Inc.
Published: 2008-10-20
License: https://open.fda.gov/license/

Arjo, Inc. / initiated 2008-10-20 / Terminated / root cause: manufacturing process

FDA source

Arjo, Inc. began a recall of 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... on 2008-10-20. The reason FDA records is "The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the hanger bar falling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0322-2009
Status: Terminated
Initiated: 2008-10-20
Posted: 2008-11-24
Terminated: 2010-08-19
Recalling firm: Arjo, Inc.
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.
Product code: FSA Lift, Patient, Non-Ac-Powered
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)