Recall Z-2661-2018 ยท FSA Lift, Patient, Non-Ac-Powered
Arjohuntleigh Magog
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.
| Date | Feb 12, 2018 |
| Status | Terminated |
| Reason | The spreader bar can detach from the scale attachment under certain conditions. |
| 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 Fo |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.