Reported Dec 26, 2012 · Terminated
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape…
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 Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.
- Lot codes and dates
- Parent SN
2,173 of 2,173 codes
SA310310978GASA310454946GASA310475517GASA310475525GASA310475536GASA310475537GASA310475540GASA310475566GASA310475575GASA310475581GASA310475582GASA310475585GASA310475591GASA310475598GASA310475600GASA310475608GASA310475609GASA310475610GASA310475611GASA310028114GRSA310028140GRSA310028149GRSA310149355GRSA310259884GASA310259951GRSA310260040GASA310260303GRSA310260308GRSA310260320GASA310260359GRSA310260383GASA310260402GASA310260553GASA310290668GASA310310883GASA310310926GASA310310993GASA310321001GASA310341381GASA310351501GASA310361698GASA310361707GASA310361785GASA310361945GASA310372076GASA310372167GRSA310372294GASA310382325GRSA310382326GRSA310382347GRSA310382364GASA310382635GASA310382657GASA310382754GASA310382814GASA310382838GASA310382839GASA310382849GASA310392898GASA310392937GR
- Parent SN
- Amount recalled
- 10,250
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
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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