GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.

FDA device recall Z-2085-2014 · posted 2014-07-21 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.

Action taken

Consignees were sent on 6/13/2014 a GE Healthcare "Urgent Medical Device Correction" letter #36103, 36104 and 36105 dated June 6, 2014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Products Details, Product Correction and Contact Information. Consignees were advised to contact Technical Support at 800-558-7044 in regard to questions on this recall.

Root cause

Software design

Status

Terminated

Product code

MHX

Quantity affected

41,992 (20,509 US; 21,483 OUS)

Distribution

Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDE

Date initiated

2014-06-13

Date posted

2014-07-21

Date terminated

2016-09-07

Location

Waukesha, WI

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