GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B6

FDA device recall Z-1175-2014 · posted 2014-03-11 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues.

Action taken

GE Healthcare sent an Urgent Field Safety Notice dated February 26, 2014, to all International consignees. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issues and Instructions, Affected Product Details Product Correction and Contact Information ( Contact Technical Support at 1-800-558-7044 or their local Service Representative). GE Healthcare determined that there were no US sites affected since all units were under GE control therefore, no customer letter was deployed in US. For questions regarding this recall call 847-277-4472.

Root cause

Software design

Status

Terminated

Product code

MHX

Quantity affected

676 units OUS

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, GREECE, ITALY, LITHUANIA, POLAND, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM

Date initiated

2014-02-28

Date posted

2014-03-11

Date terminated

2015-04-29

Location

Waukesha, WI

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