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Terminated

GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another.

FDA Recall Z-2117-2013 · Posted 2013-08-28

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2013-04-03
Date Terminated2016-07-25
Product Quantity4807 (2167 US, 2207 OUS, & 434 unknown.

Reason for Recall

GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.

Firm Action

GE Healthcare "Urgent Medical Device Correction" letter dated April 3, 2013 to all affected customers. The letter was addressed to Healthcare Administrator / Risk manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Product, Safety Instructions, Affected Product Details, and Product Correction. For questions contact Technical Support at 1-800-558-7044.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA Nationwide including DC and PR except ND and the countries of: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, HONDURAS, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNSIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, BOLIVIA, HONG KONG, JAMAICA, PHILIPPINES, SOUTH KOREA, TRINIDAD TOBAGO, URUGUAY, VENEZUELA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053121TRAM MODULEGE Healthcare · 2006-04-05

Official Source

View FDA Recall →

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

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