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U.S. Department of Health and Human Services

Class 2 Device Recall BHM Medical Scales

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  Class 2 Device Recall BHM Medical Scales see related information
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
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.
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
For Additional Information Contact Ms. Traci Giovenco
630-307-2756
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.
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
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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