Reported Sep 4, 2013 · Terminated
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor…
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 HealthcareDash 3000Dash 4000 and Dash 5000
- Product UsageThe intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients
- Lot codes and dates
- Mfg Lot or Serial #S
2,171 of 2,171 codes
AAB04397901GRSD007210479GRSD007231230GRSD007241751GRSD007366729GRSD007387285GRSD007387288GRSD007387291GRSD007387292GRSD007387294GRSD007439614GRSD008056174GRSD008076950GRSD008087478GRSD008138396GRSD008168769GRSD008219818GRSD008219821GRSD008356627GRSD008388272GRSD008388551GRSD008419461GRSD008419463GRSD008419495GRSD008421124GRSD008429787GRSD008429950GRSD008452355GRSD008452399GRSD008463177GRSD008516155GRSD008516281GRSD009037533GRSD009047690GRSD009088931GRSD009088944GRSD009099025GRSD009119669GRSD009121032GRSD009121171GRSD009129978GRSD009141371GASD009141699GRSD009151940GASD009182687GRSD009182701GRSD009182715GRSD009193075GRSD009193076GRSD009193084GRSD009193086GRSD009223767GRSD009223886GRSD009234001GRSD009234021GRSD009244557GRSD009244558GRSD009244559GRSD009244560GRSD009244564GR
- Mfg Lot or Serial #
- Amount recalled
- 28,120 *14,709 US & 13,411 OUS)
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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