Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used ...
FDA Device Recall #Z-2660-2018 — Class II — February 12, 2018
Recall Summary
| Recall Number | Z-2660-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 12, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arjohuntleigh Magog |
| Location | Magog, Quebec |
| Product Type | Devices |
| Quantity | 874 Units (both styles) |
Product 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 for Recall
The spreader bar can detach from the scale attachment under certain conditions.
Distribution Pattern
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.
Lot / Code Information
Product Code 700-19485: starting from serial number 300146551 up to serial number 300220716.
Other Recalls from Arjohuntleigh Magog
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0802-2019 | Class II | ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy ... | Dec 19, 2018 |
| Z-2661-2018 | Class II | Q-Connect 272 KG Scale used with Maxi Sky 2 cei... | Feb 12, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.