Reported Sep 4, 2013 · Terminated
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product…
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?
- SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE
- Patient Data Module) Product UsageThe Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes
- Lot codes and dates
- Mfg Lot or Serial #
2,170 of 2,170 codes
SA310290653GASA310290655GASA310290657GASA310290659GASA310290661GASA310290748GASA310290749GASA310290750GASA310290754GASA310290755GASA310290756GASA310290757GASA310290758GASA310290759GASA310361647GASA310361877GASA310372108GASA310393017GASA310393052GASA310382648GASA310382626GASA310382631GASA310382729GASA310382761GASA310393037GASA310393054GASA310393071GASA310393073GASA310351531GASA310361792GASA310361798GASA310361801GASA310361803GASA310361804GASA310361805GASA310361807GASA310361808GASA310361815GASA310361820GASA310361838GASA310361840GASA310361841GASA310393150GASA310393155GASA310393162GASA310393165GASA310393166GASA310393167GASA310393170GASA310393171GASA310393173GASA310393175GASA310321055GASA310321062GASA310361949GASA310382418GASA310382450GASA310382499GASA310382513GASA310382608GA
- Mfg Lot or Serial #
- Amount recalled
- 16,462 (8497 US, 7307 OUS, & 658 unlocated)
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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