GE Healthcare, TRAM MODULE, High-acuity patient monitoring
Medical device recall Z-2117-2013. Published in FDA’s Enforcement Report on Sep 4, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 4, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 4807 (2167 US, 2207 OUS, & 434 unknown. how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
4807 (2167 US, 2207 OUS, & 434 unknown., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # RT412081449GA RT412081483GA RT412091489GA RT412091490GA RT412091492GA RT412091510GA RT412091511GA RT412091517GA RT412091522GA SBB12281535GA RT412101534GA SBB12281525GA SBB12281528GA SBB12281561GA SBB12301640GA…
Every code shown here, 1,997 characters
Mfg Lot or Serial # RT412081449GA RT412081483GA RT412091489GA RT412091490GA RT412091492GA RT412091510GA RT412091511GA RT412091517GA RT412091522GA SBB12281535GA RT412101534GA SBB12281525GA SBB12281528GA SBB12281561GA SBB12301640GA SBB12361656GA SBB12361658GA SBB12361659GA SBB12361660GA SBB12361661GA SBB12361662GA SBB12361663GA SBB12301635GA RT411220584GA RT412081484GA RT412091488GA RT412091501GA RT412101576GA RT412101599GA RT412101601GA RT412101604GA RT412101605GA RT412101606GA RT412101609GA RT412101611GA RT412101621GA RT412101624GA RT412101626GA RT412101628GA RT412101629GA RT412101632GA RT412101646GA RT412101655GA RT412101657GA RT412101661GA RT412101662GA RT412101663GA RTW11346657GA RTW11346667GA RTW11366669GA RTW11366672GA RTW11366673GA RTW11366674GA RTW11366691GA RTW11366695GA RTW11366697GA RTW11366700GA RTW11366701GA RTW11366702GA RTW11366704GA RTW11366712GA RTW11366715GAMKE RTW11366721GA RTW11366722GA RTW11366724GA RTW11366725GA RTW11366726GA RTW11366731GA RTW11366736GA RTW11366737GA RTW11366738GA RTW11366739GA RTW11366742GA RTW11366747GA RTW11366748GA RTW11366751GA RTW11366752GA SBB12281564GA SBB12281575GA SBB12301617GA SBB12301618GA SBB12301620GA SBB12301626GA SBB12301627GA SBB12301628GA SBB12301630GA SBB12301631GA SBB12131373GA SBB12301629GA SBB12281536GA SBB12281539GA SBB12281542GA SBB12281549GA SBB12281563GA SBB12301623GA SBB12301624GA SBB12301632GA SBB12301633GA SBB12301634GA SBB12301636GA SBB12301637GA SBB12301638GA SBB12301639GA SBB12301641GA SBB12301642GA SBB12301643GA SBB12301644GA SBB12301645GA SBB12301646GA RT412081429GA RT412081448GA RT412091507GA RT412101533GA RT412101536GA RTW11366717GA RTW11366732GA RTW11376817GA RTW11376819GA RTW11376821GA SBB12281533GA SBB12281537GA SBB12281538GA SBB12281540GA SBB12281545GA SBB12281548GA SBB12281551GA SBB12281552GA SBB12281553GA SBB12281554GA SBB12281556GA SBB12281557GA SBB12281558GA SBB12281562GA SBB12281565GA SBB12281566GA SBB12281574GA SBB12281576GA SBB12301621GA SBB12301622GA SBB12301625GA RTW11366716GA…
FDA’s list runs to 67,352 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- District of Columbia
- Puerto Rico
They leave out North Dakota.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 3, 2013.
- FDA classified it on Aug 28, 2013.
- FDA’s Enforcement Report published it on Sep 4, 2013.
- FDA terminated it on Jul 25, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 67,352 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.