Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2661-2018Class II

Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient...

Arjohuntleigh Magog, Inc. / initiated 2018-02-12 / Terminated / root cause: manufacturing process

Arjohuntleigh Magog began a recall of Q-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... on . FDA classified it as Class II and gives the reason as "The spreader bar can detach from the scale attachment under certain conditions". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2661-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arjohuntleigh Magog, Inc.
Product
Q-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.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
The spreader bar can detach from the scale attachment under certain conditions.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
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]
Quantity in commerce
874 Units (both styles)
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.
Product codes and lots
Product Code 700-19490: starting from serial number 300142013 up to serial number 300219867.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2661-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2660-2018Class IITerminatedVoluntary: Firm initiated
Z-2661-2018Class IITerminatedVoluntary: Firm initiated