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FDA Medical Device Recalls (openFDA)

Arjo, Inc.: 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.

Recall number
Z-0322-2009
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.
Status
Terminated
Initiated
2008-10-20
Posted
2008-11-24
Terminated
2010-08-19
Reason
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
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
38 units
Distribution
Nationwide Distribution.
Lot, serial or model codes
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.
510(k) numbers
not on file
PMA numbers
not on file
Product code
FSA
Firm FEI
1419652
Firm city
Roselle
Firm state
IL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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