CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a profes

FDA device recall Z-0927-2014 · posted 2014-02-04 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communicatio

Action taken

GE Healthcare sent an "Urgent Medical Device Correction" letter dated December 20, 2013 to all affected customers. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter addressed the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Call Technical Support at 1-800-558-7044 or your local Service Representative).

Root cause

Component change control

Status

Terminated

Product code

MHX

Quantity affected

12, 945 units (6,239 US, 6,706 OUS)

Distribution

Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Australia, Austria, Azerbaijan, Bahrain, Belgium, BRAZIL, Canada, CHILE, COSTA RICA, Cyprus, Czech Republic, Denmark,

Date initiated

2013-12-20

Date posted

2014-02-04

Date terminated

2016-05-02

Location

Waukesha, WI

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