VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref recalled over labeling errors
- Recall date
- June 19, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Vascular Technology, Inc. recalls VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascu…
- Recall number
- Z-3026-2018
- FDA classification
- Class II
- Brand / firm
- Vascular Technology, Inc.
- Sold / distributed
- US Distribution to state of: CA.
Why it was recalled
Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
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