FDA Recall Terminated

Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities.

Recall: Z-2660-2018 · Initiated February 12, 2018

Recall

Recall Number
Z-2660-2018
Event Number
80465
Firm
Arjohuntleigh Magog 2001 Rue Tanguay Magog Canada Quebec
FEI Number
3002655016
Product Code
FSA
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
February 12, 2018
Terminated
August 20, 2020

Description

Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities.

Reason

The spreader bar can detach from the scale attachment under certain conditions.

Action

Thefirm, ARJO, sent an "Urgent-A Field Safety Notice" and Customer Response Forms to affected customers by common carrier and signature required. All affected customers need to ensure that all caregivers and users of the affected devices a remade aware of the Field Safety Notice and all listed devices at their facility are available to be corrected during service technician visit. Affected customers need also to review the Field Safety Notice, acknowledge receipt and understanding of the Field Safety Notice and the required actions by completing, signing and returning the Customer Response Form to the local Arjo office. The Arjo Sales and Service office shall arrange Arjo service technician to visit the facilities to carry out the upgrade of the scales attachment on Maxi Sky 2 ceiling lifts. If you have any further questions or require assistance completing the Customer Response Form, please contact Arjo via email at [email protected]

Distribution

Worldwide distribution: US (nationwide) to states of: CO, FL, IA, IL, KY, MN, NY, PH, and WA; and countries of: Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Singapore, Swiss, Turkey, United Kingdom, and United Arab Emirates.

Quantity

874 Units (both styles)