Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following C

FDA device recall Z-0471-2015 · posted 2014-11-26 · Terminated

Recall details

Recalling firm

Toshiba American Medical Systems Inc

Reason for recall

Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.

Action taken

Toshiba sent an Urgent Medical Device Correction letter dated November 5, 2014, to all affected customers. Customers were asked to refrain from using the function parameters for the entire heart and the left-ventricular volume curve until corrective actions have been taken. Customers were instructed to share this information with all users and reviewing radiologist as well as clinical engineering or Biomedical group at facility. Please complete and return the attached form and fax it to the toll free number at the top of the form 877-349-3054. This form can also be sent via email to raffairs@tams.com. Revised software to prevent occurrence of this problem will be installed on the system. When the new software becomes available the Toshiba service representative will contact for an appointment to install it on the system. Customers with questions were instructed to call 800-421-1968 or contact their local Toshiba Representative at 800-521-1968.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

1 unit within the U.S. only

Distribution

US Nationwide Distribution to CA, MA, MD

Date initiated

2014-11-05

Date posted

2014-11-26

Date terminated

2015-10-09

Location

Tustin, CA

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