Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-3026-2018

June 19, 2018

Class II

Product summary

Firm
Vascular Technology, Inc.
Event
Event 80527
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-3026-2018

Official wording

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

Code information: Serial Numbers: 14329-001, 14329-002, 14329-003, 14329-004, 14329-005, 14329-006, 14329-007, 14329-008, 14329-009, and 14329-010.

Distribution pattern: US Distribution to state of: CA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled