Z-3026-2018 Class II Terminated
FDA device recall Z-3026-2018 was initiated by Vascular Technology, Inc. on June 19, 2018 and is designated Class II. Reason for recall: Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver The recall status is terminated (terminated January 30, 2020). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 19, 2018
- Initiation Date
- June 19, 2018
- Termination Date
- January 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
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 Pattern
US Distribution to state of: CA.
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.