Z-1342-2013Class II
Molift Smart 150
Etac A/S / initiated 2013-02-15 / Terminated / root cause: manufacturing process
Moller Vital began a recall of Molift Smart 150 on . FDA classified it as Class II and gives the reason as "The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1342-2013
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Etac A/S
- Product
- Molift Smart 150
- Product code
- FSA Lift, Patient, Non-Ac-Powered
- Reason for recall
- The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user.
- Root cause tag
- manufacturing process
- FDA root cause
- Employee error
- Action
- Molift Group AS issued a Field Safety Notice letter to all affected customers. The letter identified the affected products, problem and actions to be taken to the Smart hoists that are already in use. Customers were instructed to make sure that all affected customers receive this information and encorage to increase attention until the affected product has been upgraded. For questions contact your local Molift representative or Customer Service at: [email protected].
- Quantity in commerce
- 7,555 units subject to review; US: 1,280 units - Foreign: 6,275 units
- Distribution
- US Nationwide Distribution: CA, FL, GA, ID, IL, KY, MA, ME, MI, MN, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VT, WA and Hawaii. Foreign Distribution:: Australia, Austria; Belgium, Denmark, Finland, France, Germany, Iceland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Spain, Sverige, Switzerland, United Kingdom.
- Product codes and lots
- Art #: 0920001 batch 1-62 and 0920002 batch 1-77; Serial Number ranges 022228 to 094103 and 100015 to 12058.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1342-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1343-2013 | 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.
