GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording sys

FDA device recall Z-0645-2010 · posted 2010-01-21 · Terminated

Recall details

Recalling firm

GE Medical Systems, LLC

Reason for recall

GE Healthcare has become aware of an issue with MAC800 laser printouts. When more than one ECG report in the file manager is batch printed in laser print, the potential exists for an incorrect patient identification or name to be displayed on the print out. Misidentification of patient data potentially contributing to delayed or incorrect treatment is then possible.

Action taken

Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated December 10, 2009. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Healthcare will provide a software upgrade to resolve the issue. A GE Healthcare representative will contact customers to schedule implementation of the correction when it is available for installation at the customer facility. Direct questions to the GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.

Root cause

Software design

Status

Terminated

Product code

DPS

Quantity affected

567

Distribution

Worldwide Distribution -- United States (CA, CO, CT, FL, IL,MD, NY, NC, OH, TN, TX, WA and WI), UNITED KINGDOM, UNITED ARAB EMIRATES, THAILAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPORE, ROMANI

Date initiated

2009-12-10

Date posted

2010-01-21

Date terminated

2013-08-06

Location

Waukesha, WI

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