Device Recall Enterprise 9000 Bed 의 리콜

Recall

63187

Class 2

Z-0477-2013

2012-11-16

2013-08-06

Terminated

United States

2016-09-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112872

Arjohuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. these incidents have occurred in high dependency and intensive therapy environments where unintended movement of the patient may have serious consequences.

Please be aware that this is not a new recall. Posting to the Internet was delayed due to a technical error. ArjoHuntleigh sent an Urgent Field Correction Recall letters dated November 16, 2012, to all affected customers, informing the accounts of reports of unintended movement of the backrest and/or thigh sections of the bed without intentional activation of the control buttons, which could have serious consequences due to the patient's links to other life supporting devices. The accounts were requested to disseminate the information to all users of the affected beds, to attach the enclosed warning labels to the outside of both head end safety sides immediately adjacent to the controls, to include a copy of the notice in the Instruction for Use Manuals for their beds, and to complete the Customer Response Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.