Z-2660-2018Class II
Quick 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 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... 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-2660-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Arjohuntleigh Magog, Inc.
- 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.
- 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 700-19485: starting from serial number 300146551 up to serial number 300220716.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2660-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2661-2018 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
