Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part...
Merge Healthcare, Inc. began a recall of Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of... on . FDA classified it as Class II and gives the reason as "Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0350-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Merge Healthcare Incorporated
- Product
- Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.
- Product code
- DQK Computer, Diagnostic, Programmable
- Reason for recall
- Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke.
- Root cause tag
- design
- FDA root cause
- Component design/selection
- Action
- Merge began notify customers via an Urgent Medical Device Recall letter on 4/6/2017 via mail. The letter identified affected product, stated the issue, and informed customers that Merge would replace affected product. A response form is requested to be returned to Merge. Questions can be sent via email to [email protected]
- Quantity in commerce
- 1,150 power strips
- Distribution
- Nationwide.
- Product codes and lots
- Part Number 04175-0008 and Part Number 13-00106-00
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0350-2018 | Class II | Terminated | Voluntary: Firm initiated |
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