PlainRecordsFDA · Medical device recall
Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The… and 1 more product
- Date
- Aug. 15, 2018
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Arjohuntleigh Magog
- Reason
- 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.
2 products in this recall
Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient…
- Product
- 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.
- Quantity
- 874 Units (both styles)
- Codes and lots
- Product Code 700-19485: starting from serial number 300146551 up to serial number 300220716.
- Recall started
- Feb. 12, 2018
- Device type
- Lift, Patient, Non-Ac-Powered
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- 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 ArjoCustomer.Response-US@Arjo.com
- Recall number
- Z-2660-2018
Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient…
- 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.
- Quantity
- 874 Units (both styles)
- Codes and lots
- Product Code 700-19490: starting from serial number 300142013 up to serial number 300219867.
- Recall started
- Feb. 12, 2018
- Device type
- Lift, Patient, Non-Ac-Powered
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- 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 ArjoCustomer.Response-US@Arjo.com
- Recall number
- Z-2661-2018
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-2660-2018, Z-2661-2018. The agency record governs; check it and the company before acting.