Z-0350-2018 Class II Terminated
FDA device recall Z-0350-2018 was initiated by Merge Healthcare, Inc. on April 6, 2017 and is designated Class II. 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. The recall status is terminated (terminated July 10, 2019). Affected quantity: 1,150 power strips.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2018
- Initiation Date
- April 6, 2017
- Termination Date
- July 10, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,150 power strips
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.
Distribution Pattern
Nationwide.
Code Information
Part Number 04175-0008 and Part Number 13-00106-00