Home / Recalls / Fujifilm Medical Systems U.S.A., Inc. / Z-1412-2021

Z-1412-2021 Class II Terminated

Recalled by Fujifilm Medical Systems U.S.A., Inc. — Lexington, MA

Recall Details

Product Type
Devices
Report Date
April 21, 2021
Initiation Date
February 18, 2021
Termination Date
February 24, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
496 units

Product Description

¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit

Reason for Recall

Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result

Distribution Pattern

CA, LA, MN, NC, UT, WI

Code Information

Lot Number: EQ194 Exp. Date: 05/31/2022

Other recalls by Fujifilm Medical Systems U.S.A., Inc.

  • Z-1775-2021 Class II — Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Syna (April 30, 2021)
  • Z-1348-2021 Class II — Synapse PACS - Radiological Image Processing System - Product Usage: intended fo (March 2, 2021)
  • Z-0932-2021 Class III — Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Typ (December 22, 2020)
  • Z-0918-2021 Class II — FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: inten (December 11, 2020)
  • Z-0878-2021 Class II — Synapse PACS Software Versions 5.1 and higher (September 11, 2020)
  • Z-0282-2021 Class II — Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web b (September 11, 2020)
  • Z-2471-2020 Class II — Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface t (May 22, 2020)
  • Z-2441-2019 Class II — Fujifilm FDR Go Plus mobile X-ray system (July 19, 2019)
  • Z-1040-2019 Class II — Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is int (January 15, 2019)
  • Z-0659-2018 Class II — Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire H (August 4, 2017)