GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or…
Medical device recall Z-0524-2013. Published in FDA’s Enforcement Report on Dec 26, 2012.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 26, 2012. Copied from openFDA on Oct 24, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 41 states named in where it went
- 10,250 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Which ones are recalled?
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.
10,250, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Codes to check against yours
Parent SN SA310310978GA SA310454946GA SA310475517GA SA310475525GA SA310475536GA SA310475537GA SA310475540GA SA310475566GA SA310475575GA SA310475581GA SA310475582GA SA310475585GA SA310475591GA SA310475598GA SA310475600GA SA310475608GA…
Every code shown here, 1,998 characters
Parent SN SA310310978GA SA310454946GA SA310475517GA SA310475525GA SA310475536GA SA310475537GA SA310475540GA SA310475566GA SA310475575GA SA310475581GA SA310475582GA SA310475585GA SA310475591GA SA310475598GA SA310475600GA SA310475608GA SA310475609GA SA310475610GA SA310475611GA SA310028114GR SA310028140GR SA310028149GR SA310149355GR SA310259884GA SA310259951GR SA310260040GA SA310260303GR SA310260308GR SA310260320GA SA310260359GR SA310260383GA SA310260402GA SA310260553GA SA310290668GA SA310310883GA SA310310926GA SA310310993GA SA310321001GA SA310341381GA SA310351501GA SA310361698GA SA310361707GA SA310361785GA SA310361945GA SA310372076GA SA310372167GR SA310372294GA SA310382325GR SA310382326GR SA310382347GR SA310382364GA SA310382635GA SA310382657GA SA310382754GA SA310382814GA SA310382838GA SA310382839GA SA310382849GA SA310392898GA SA310392937GR SA310393202GA SA310393246GA SA310393263GR SA310403312GA SA310403374GA SA310413458GA SA310413473GA SA310413495GA SA310413534GA SA310413537GA SA310413544GA SA310413559GA SA310413560GA SA310423573GA SA310423577GA SA310423583GA SA310423635GA SA310423723GA SA310423753GR SA310423772GA SA310423978GR SA310424012GA SA310424028GA SA310424038GA SA310434058GA SA310434122GA SA310434123GA SA310434137GA SA310434153GA SA310434242GA SA310444248GA SA310444272GA SA310444289GA SA310444494GA SA310444521GA SA310444864GA SA310455017GA SA310455033GA SA310455119GA SA310455121GA SA310465295GA SA310475464GA SA310475481GA SA310475489GA SA310475501GA SA310475510GA SA310496378GA SA310496383GA SA310496384GA SA310496386GA SA310496387GA SA310496388GA SA310496393GA SA310496394GA SA310496401GA SA310496402GA SA310496410GA SA310496411GA SA310496418GA SA310496428GA SA310496447GA SA310496450GA SA310496456GA SA310496457GA SA310496462GA SA310496467GA SA310496469GA SA310496470GA SA310496471GA SA310496472GA SA310496483GA SA310496489GA SA310496490GA SA310496492GA SA310496499GA SA310475626GA SA310475628GA SA310475629GA SA310475630GA SA310475634GA SA310475639GA SA310475649GA…
FDA’s list runs to 151,586 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution, including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, LA, KS, KY, LA, ME,MD, MA, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN,TX, UT,VA, WA, WT, WY and the countries of the UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAK IA, SINGAPORE, SAUDI ARABIA, QATAR, POLAND, PERU, PANAMA, NORWAY, NEW ZEALAND, NETHERLAND, MEXICO, MALAYSIA, LEBANON, KUWAIT, KOREA, JAPAN, ITALY, INDONESIA, INDIA, IRELAND, GERMANY FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHILE CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, ARGENTINA, and ALGERIA.
The states and territories these words name
41 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 17, 2012.
- FDA classified it on Dec 14, 2012.
- FDA’s Enforcement Report published it on Dec 26, 2012.
- FDA terminated it on Dec 3, 2013.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 151,586 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 23, 2026 and checked Oct 23, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 24, 2026.