Medical device recalls Moderate risk

Merge Healthcare product recalled over fire hazard

Recall date
April 6, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Merge Healthcare, Inc. recalls Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-0010…
Recall number
Z-0350-2018
FDA classification
Class II
Brand / firm
Merge Healthcare, Inc.
Sold / distributed
Nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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