Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).

FDA Recall Z-1606-2015 · Posted 2015-05-12

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeMHX
Date Initiated2015-05-04
Date Terminated2015-09-15
Product Quantity110 (83 units US, 27 units OUS)

Reason for Recall

The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patients condition and delayed or missed life sustaining patient treatment

Firm Action

GE Healthcare sent an Urgent Medical Device Correction letter dated May 1, 2015, to all affected consignees. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132533CARESCAPE MONITOR B450GE Healthcare Finland Oy · 2013-12-04K131223CARESCAPE MONITOR B650GE Healthcare Finland Oy · 2013-08-28K131414CARESCAPE MONITOR B850GE Healthcare Finland Oy · 2013-08-28K102239CARESCAPE MONITOR B650GE Healthcare Finland Oy · 2010-10-18K092027CARESCAPE 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.

↑