VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5

FDA device recall Z-0169-2014 · posted 2013-11-06 · Terminated

Recall details

Recalling firm

Vital Images, Inc.

Reason for recall

Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.

Action taken

Vita Images, Inc. sent an Urgent Medical Device Recall letter on October 21, 2013, to all affected customers via USPS First class mail. The letter described the Reason for Voluntary Recall (Nature of software issue, Potential scenarios which exhibit the issue), Risk to Health (How to confirm if the Snapshots are correct), Actions to be Taken by Customer (Recommended Next Steps which includes to complete and sign the enclosed Effectiveness Check Form and send to fieldnotices@vitalimages.com or fax to 1-952-540-3717), and Actions Being Taken by Vital Images (Vital Images Contact Information: If you have questions, direct Vital Images customers and customers of Toshiba America Medical Systems (TAMS) should contact Vital Images Customer Support at +1-800-208-3005, or by e-mail to support@vitalimages.com; customers through a distributor will be contacted by that distributor). For questions regarding this recall call 952-487-9574.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

598

Distribution

Nationwide Distribution - all states in continental USA including DC but not OK or RI. OUS: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Honduras, Hong Kong,

Date initiated

2013-10-21

Date posted

2013-11-06

Date terminated

2015-01-16

Location

Minnetonka, MN

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