Recall Z-0350-2018 ยท DQK Computer, Diagnostic, Programmable
Merge Healthcare, Inc.
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.
| Date | Apr 6, 2017 |
| Status | Terminated |
| 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. |
| 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 recall@merge.com |
| Quantity | 1,150 power strips |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152864 | Merge Hemo Merge Healthcare Incorporated, Apr 7, 2016 |