Reported Sep 4, 2013 · Terminated
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, TRAM MODULE, High-acuity patient monitoring
- Product UsageThe 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
- Lot codes and dates
- Mfg Lot or Serial #SB
2,170 of 2,170 codes
RT412081449GART412081483GART412091489GART412091490GART412091492GART412091510GART412091511GART412091517GART412091522GASBB12281535GART412101534GASBB12281525GASBB12281528GASBB12281561GASBB12301640GASBB12361656GASBB12361658GASBB12361659GASBB12361660GASBB12361661GASBB12361662GASBB12361663GASBB12301635GART411220584GART412081484GART412091488GART412091501GART412101576GART412101599GART412101601GART412101604GART412101605GART412101606GART412101609GART412101611GART412101621GART412101624GART412101626GART412101628GART412101629GART412101632GART412101646GART412101655GART412101657GART412101661GART412101662GART412101663GARTW11346657GARTW11346667GARTW11366669GARTW11366672GARTW11366673GARTW11366674GARTW11366691GARTW11366695GARTW11366697GARTW11366700GARTW11366701GARTW11366702GARTW11366704GA
- Mfg Lot or Serial #
- Amount recalled
- 4807 (2167 US, 2207 OUS, & 434 unknown.
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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