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Terminated

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

FDA Recall Z-2085-2014 · Posted 2014-07-21

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2014-06-13
Date Terminated2016-09-07
Product Quantity41,992 (20,509 US; 21,483 OUS)

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO, MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192239WavelinQ Plus EndoAVF SystemC.R. Bard, Inc. · 2019-10-17K132523MYOPERFUSIONToshibamedical Systems Corporation · 2013-12-12K131223CARESCAPE MONITOR B650GE Healthcare Finland Oy · 2013-08-28K131414CARESCAPE MONITOR B850GE Healthcare Finland Oy · 2013-08-28K092027CARESCAPE MONITOR B850Ge Medical Systems Information Technologies · 2009-08-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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