Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 The display, processing, archiving, and communication of da

FDA device recall Z-1250-2011 · posted 2011-02-15 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. Measurements taken on the CT Images on the CT system are different from the Xeleris Workstation 2. Inaccurate PET SUV values may be calculated when data is retrieved from PACS after being processed in the Xeleris. 3. Wrong marking of Early and Late result series on display in Bra

Action taken

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 12, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to please ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. A GE Healthcare Service representative will perform the required software update on each affected system. If you have any questions or concerns regarding this notification, contact your local GE Healthcare Service Representative. You may also contact GE Healthcare call center in US or Canada at 800-437-1171 and other countries at 262-896-2890.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

6046

Distribution

Worldwide distribution: USA including DC, PR, and Guam; and countries including: AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA, AZERBAIJAN, BELGIUM, BOSNIA & HERZEGOVIA, BULGARIA, BRAZIL, CANADA, CHILE, CHIN

Date initiated

2011-01-12

Date posted

2011-02-15

Date terminated

2012-10-16

Location

Waukesha, WI

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