VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
FDA Recall Z-3026-2018 · Posted None
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Recalling FirmVascular Technology, Inc.
Recall StatusTerminated
Product CodeDPW
Date Initiated2018-06-19
Date Terminated2020-01-30
Product Quantity10 units
Reason for Recall
Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver
Firm Action
The firm, Vascular Technology, Inc., "URGENT: MEDICAL RECALL DEVICE" letter dated June 18, 2018, to its customer on June 19, 2018. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine inventory and return all product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall.
If you have any questions, contact VP Sales person at 603-594-9700.
Root Cause
Labeling Change Control
Distribution Pattern
US Distribution to state of: CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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