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Class 2 Device Recall BHM Medical Scales |
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Date Initiated by Firm |
December 19, 2007 |
Date Posted |
February 26, 2008 |
Recall Status1 |
Terminated 3 on November 18, 2009 |
Recall Number |
Z-1136-2008 |
Recall Event ID |
46210 |
Product Classification |
Medical Scales - Product Code FRW
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Product |
BHM Medical Scales, 1000 lb. scales weight limit; Part Number 700.00525; Manufactured by BHM Medical Inc., Magog, QC, Canada; These scales were sold for installation on the Model V10 and Model Maxisky fixed ceiling lifts manufactured by BHM Medical.
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Code Information |
Part 700.00525, Serial Numbers: ERSC-3064, ERSC-3065, ERSC-3066, ERSC-3068, ERSC-5858, ERSC-5859, ERSC-5860, ERSC-5861, ERSC-5864, ERSC-5866, ERSC-6765, ERSC-6767, ERSC-6768, ERSC-7729, ERSC-7742, ERSC-7769, ERSC-7776, ERSC-7779, ERSC-7780, ERSC-7781, ERSC-7784, ERSC-7787, ERSC-7789, ERSC-7790, ERSC-7791, and ERSC-8038, |
Recalling Firm/ Manufacturer |
Arjo, Inc. 50 Gary Ave Ste A Roselle IL 60172-1684
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For Additional Information Contact |
Ms. Traci Giovenco 630-307-2756
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Manufacturer Reason for Recall |
Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.
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FDA Determined Cause 2 |
Device Design |
Action |
Arjo sent Urgent Device Field Correction Notification letters dated 12/19/07 to the end user accounts who received the affected scales, advising them of the potential for the hanger bar assembly to detach. The accounts were given the option immediately stopping use of the lifts with the affected scales or removing the scales from the lift so the lift can continue to be used. Instructions for removal of the scales were provided with the letter. The accounts were requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter, and indicating whether they will complete the correction upon receipt of the correction parts or if they require the assistance of an Arjo Service Technician. |
Quantity in Commerce |
26 scales |
Distribution |
Nationwide including the states of Alabama, Arizona, California, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Washington and Wisconsin. |
Total Product Life Cycle |
TPLC Device Report
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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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