Recall Z-0350-2018— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2017-04-06, terminated 2019-07-10. It names one FDA 510(k) clearance: K152864. 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.. Reason: 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..
- Recalling firm
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-06
- Terminated
- 2019-07-10
- Firm location
- Hartland, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.