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Terminated

GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered. The physiological parameters monitored include ECG, noninvasive blood pressure, non-invasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display.

FDA Recall Z-1522-2011 · Posted 2011-03-03

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2011-01-28
Date Terminated2012-05-29
Product Quantity2346

Reason for Recall

GE Healthcare has become aware of a potential for loss of patient monitoring when ApexPro Telemetry System is used in conjunction with a mirrored view CARESCAPE CIC Pro in combination monitoring mode (combo mode). The safety issue includes the potential for a delay in annunciation of audible alarms when used in combo mode, and may result in the delay of treatment of a cardiac event.

Firm Action

GE sent an "Urgent Medical Device Correction" letter dated December 29, 2010. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Product Correction, Safety Instruction and Contact Information. Customers were instructed to contact Technical Support or their local Service Representative with any questions regarding this medical device. For any questions regarding this recall call 262-573-4122.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT,NE, NJ, NM, NY, NC, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY. and the UNITED KINGDOM, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH KOREA, RUSSIA, NORWAY, NEW ZEALAND, NETHERLANDS, MALAYSIA, JAPAN, ITALY, ISRAEL, IRELAND, GERMANY, FRANCE, FINLAND, DENMARK, CUBA, CHINA, CANADA, AUSTRIA, AUSTRALIA, POLAND.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080251APEXPRO TELEMETRY SYSTEMSGe Medical Systems Information Technologies · 2008-06-20

Official Source

View FDA Recall →

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

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