The following document is a copy of a Press Release from Arjo, Inc related to the Class I Medical Device Recall of the Arjo Alenti Lift Hygiene Chair. See nearby for the link to the recall notice.
FOR IMMEDIATE RELEASE
July 7, 2004
ARJO, INC. Announces a Nationwide, Voluntary Recall of the ALENTI Patient Lifts
Quality Assurance Department
1.800.323.1245, ext. 6140 or 6103
Arjo, Inc. today announced that it is voluntarily conducting, a Class I recall for two models, CDB8003-01 (with out scale) and CDB8053-01 (with scale) of its ALENTI Patient Lifts because of tipping problems that could result in serious patient injury. The FDA defines a Class I recall as a situation in which there is reasonable probability that the use of the product will cause serious adverse health consequences or death.
Arjo is aware of reports of the lift tipping, causing the patient to fall and be injured. One of these incidents resulted in death.
This recall involves 885 ALENTI Patient Lifts that could possibly tip over during use. No other Arjo, Inc. devices are involved in this action. The ALENTI manufacturer's investigation concluded that tipping incidents did not occur due to product malfunction. The ALENTI tipping incidents occurred due to several usage factors not related to product quality, including resident assessment, interference with other equipment, lift elevation and repositioning patient after bath. However, failure to properly use the safety belt and failure to maintain the lift castors have contributed to patient injuries.
The ALENTI manufacturer concluded that the usage factors regarding the tipping incidents could be corrected and or managed by clarifying and reiterating key instructions to the ALENTI users. The ALENTI Operating and Product Care Instructions were updated to enhance the correct use of the ALENTI, including correct use of the Safety Belt.
All affected customers were formally notified via certified or express mail of the ALENTI Recall on June 8, 2004. Affected customers received a laminated Safety Advise Notice, one Updated Operating and Product Care Instructions and one Safety Belt per ALENTI. Affected customers have also been advised to complete a Customer Response Form and return it to Arjo, Inc. Quality Assurance Department.
Arjo, Inc. is voluntarily cooperating with the Food and Drug Administration to ensure that all affected customers are notified of this issue. Arjo, Inc. formally notified the Food and Drug Administration on June 1, 2004.
Arjo, as a global leader in patient lifts, is committed to ongoing product surveillance to assure product safety and reliability.
Any inquiries regarding this action should be directed to the Quality Assurance Department using the above referenced toll-free number.