FDA recall Z-3026-2018

Product

VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

Reason for recall

Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver

Distribution

US Distribution to state of: CA.

Key facts

Status

Terminated

Initiation date

2018-06-19

Report date

2018-09-19

Termination date

2020-01-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nashua, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3026-2018