U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Medical Scales - Product Code FRW
원인
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.
조치
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.
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.
제품 설명
BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5; || These scales were sold for installation on or as a component of the following patient lifts: || a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: || Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift; || Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift; || Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift; || b) Manufactured for Sunrise Medical, Longmont, CO 80503: || Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale; || Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale, Model HPL-600WBSC; || Part Number: 9600132.06, Hoyer-600 Wide Opening Patient Lifter with Scale