GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE " Monitor B850 is a multi-pa

FDA device recall Z-1801-2010 · posted 2010-06-11 · Terminated

Recall details

Recalling firm

Ge Healthcare, Llc

Reason for recall

GE Healthcare has become aware of a safety issue associated with the CARESCAPE" Monitor B850 when monitoring ECG. The safety issue includes the potential for a delay in treatment.

Action taken

The customers were sent on May 6, 2010, a GE Healthcare "Urgent Medical Device Correction" letter dated April 22, 2010. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, Director of Biomedical Engineering. The letter listed the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information. The customers were instructed to immediately discontinue use of the "Update Lead Set" function until the device software has been upgraded. If you have any questions regarding this medical device correction or identification of affected items, please contact Technical Support at 1-800-558-7044, or your local service representative.

Root cause

Software design

Status

Terminated

Product code

MHX

Quantity affected

798 units. (229 USA, 569 OUS)

Distribution

Worldwide distribution: USA including CO, MA, NC, WI, and countries of UNITED KINGDOM, SWITZERLAND, SWEDEN, SPAIN, SINGAPORE, PORTUGAL, NORWAY NETHERLANDS, ITALY, INDIA, GERMANY, FRANCE, FINLAND, BELG

Date initiated

2010-05-06

Date posted

2010-06-11

Date terminated

2012-06-05

Location

Waukesha, WI