Reported Feb 20, 2013 · Terminated

GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use…

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 Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
Lot codes and dates
  • SERIAL NUMBER

    2,173 of 2,173 codes

    • SEW1181782HA
    • SEW11243524HA
    • SEW11223123HA
    • SEW11223122HA
    • SEW11223121HA
    • SEW11223108HA
    • SEW11223107HA
    • SEW11223106HA
    • SEW11223092HA
    • SEW11223086HA
    • SEW11223085HA
    • SEW11223082HA
    • SEW11223070HA
    • SEW11223022HA
    • SEW11223019HA
    • SEW11223011HA
    • SEW11222999HA
    • SEW11222997HA
    • SEW11202780HA
    • SEW11202778HA
    • SEW11202775HA
    • SEW11202753HA
    • SEW11202750HA
    • SEW11202749HA
    • SEW11202746HA
    • SEW11202745HA
    • SEW11202744HA
    • SEW11202742HA
    • SEW11202741HA
    • SEW11202740HA
    • SEW11202739HA
    • SEW11202737HA
    • SEW11202736HA
    • SEW11202717HA
    • SEW11202716HA
    • SEW11202715HA
    • SEW11202713HA
    • SEW11202712HA
    • SEW11202711HA
    • SEW11202709HA
    • SEW11202708HA
    • SEW11202706HA
    • SEW11202705HA
    • SEW11202704HA
    • SEW11202703HA
    • SEW11202702HA
    • SEW11202700HA
    • SEW11202697HA
    • SEW11202690HA
    • SEW11202687HA
    • SEW11202682HA
    • SEW11202401HA
    • SEW11202400HA
    • SEW11202399HA
    • SEW11202398HA
    • SEW11202397HA
    • SEW11202395HA
    • SEW11202394HA
    • SEW11202390HA
    • SEW11202385HA
Amount recalled
2813

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 27, 2014 · Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.