510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0412-2009

Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale. A Non-AC-Powered Patient Lift. BHM Medical...

Arjo, Inc. / initiated 2008-10-30 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Arjo, Inc. began a recall of Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale. A Non-AC-Powered Patient Lift. BHM Medical Inc., Magog, QC, Canada. Model KM560101, and Model... on . The reason FDA records is "If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0412-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arjo, Inc.
Product
Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale. A Non-AC-Powered Patient Lift. BHM Medical Inc., Magog, QC, Canada. Model KM560101, and Model KM560001 - Maxi 500 with 2-Point Spreader Bar, if it was equipped with the optional scale kit 700.05505. The Maxi 500 is a mobile passive lifter, intended to be used for lifting and transferring of patients in hospitals, nursing homes of other health care facilities.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment.
Root cause tag
manufacturing process
FDA root cause
Employee error
Action
Arjo, Inc. sent an Urgent Device Recall Customer Notification letter dated 10/29/08 to all affected end users to the attention of the Administrator/Risk Manager via UPS 2nd day on the 10/30/08. The letters informed the accounts of the potential for the hanger bar to detach from the scale if the spring pin is not replaced into the pivot bolt after performing maintenance on the lift. The accounts were advised to review the enclosed Urgent Field Safety Notice, note the affected model and serial numbers, and inspect their lifts for the presence of the spring pin in the pivot bolt. If the user finds that the spring pin is missing, they are instructed to immediately stop using the lift and contact their Arjo representative. The accounts were also instructed to remove previous versions of the Operating and Product Care instructions, and replace them with the current version 001.20815.EN Rev3 dated October 2008 provided with the letter, ensuring that the proper personnel are made aware of the changes outlined in the Field Safety Notice. Direct questions to the Arjo, Inc. Quality Department at 800-323-1245, ext. 6118. The accounts were also instructed to complete and fax (888-594-2756) to Arjo, Inc. 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 Field Safety Notice.
Quantity in commerce
44 lifts, 2 scale kits
Distribution
Nationwide Distribution.
Product codes and lots
Model KM560101, serial numbers: KM5611219, KM5611322, KM5611076, 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, KM5611084, KM5610813, KM5611290, KM5610667, and KM5611321;  Scale model 700.05505, serial numbers: SO#5140275 and SO#5156094.