SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data…
Medical device recall Z-2116-2013. Published in FDA’s Enforcement Report on Sep 4, 2013.
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 Sep 4, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 16,462 (8497 US, 7307 OUS, & 658 unlocated) 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 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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The 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.
16,462 (8497 US, 7307 OUS, & 658 unlocated), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # SA310290653GA SA310290655GA SA310290657GA SA310290659GA SA310290661GA SA310290748GA SA310290749GA SA310290750GA SA310290754GA SA310290755GA SA310290756GA SA310290757GA SA310290758GA SA310290759GA SA310361647GA…
Every code shown here, 1,994 characters
Mfg Lot or Serial # SA310290653GA SA310290655GA SA310290657GA SA310290659GA SA310290661GA SA310290748GA SA310290749GA SA310290750GA SA310290754GA SA310290755GA SA310290756GA SA310290757GA SA310290758GA SA310290759GA SA310361647GA SA310361877GA SA310372108GA SA310393017GA SA310393052GA SA310382648GA SA310382626GA SA310382631GA SA310382729GA SA310382761GA SA310393037GA SA310393054GA SA310393071GA SA310393073GA SA310351531GA SA310361792GA SA310361798GA SA310361801GA SA310361803GA SA310361804GA SA310361805GA SA310361807GA SA310361808GA SA310361815GA SA310361820GA SA310361838GA SA310361840GA SA310361841GA SA310393150GA SA310393155GA SA310393162GA SA310393165GA SA310393166GA SA310393167GA SA310393170GA SA310393171GA SA310393173GA SA310393175GA SA310321055GA SA310321062GA SA310361949GA SA310382418GA SA310382450GA SA310382499GA SA310382513GA SA310382608GA SA310382647GA SA310382649GA SA310382663GA SA310393156GA SA310393158GA SA310393164GA SA310393169GA SA310393177GA SA310259944GA SA310331337GA SA310331342GA SA310331343GA SA310331345GA SA310331349GA SA310331351GA SA310341373GA SA310341376GA SA310341387GA SA310341388GA SA310341399GA SA310341400GA SA310341401GA SA310341402GA SA310341403GA SA310341406GA SA310382386GA SA310382391GA SA310382472GA SA310382476GA SA310382477GA SA310382479GA SA310382484GA SA310382494GA SA310382618GA SA310382619GA SA310382634GA SA310382636GA SA310382645GA SA310382378GA SA310382449GA SA310382511GA SA310382606GA SA310382607GA SA310382610GA SA310382612GA SA310382613GA SA310382615GA SA310382616GA SA310382642GA SA310382652GA SA310382656GA SA310382664GA SA310423572GA SA310423573GA SA310290745GA SA310290753GA SA310413471GA SA310413476GA SA310423587GA SA310423607GA SA310413493GA SA310413498GA SA310413500GA SA310413507GA SA310413514GA SA310413524GA SA310413535GA SA310423604GA SA310423606GA SA310423611GA SA310423617GA SA310423619GA SA310423621GA SA310423626GA SA310423640GA SA310423649GA SA310423650GA SA310423730GA SA310423821GA SA310423825GA SA310423836GA…
FDA’s list runs to 246,231 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 - USA Nationwide including DC and PR except ND and the countries of: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, HONDURAS, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNSIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, BOLIVIA, HONG KONG, JAMAICA, PHILIPPINES, SOUTH KOREA, TRINIDAD TOBAGO, URUGUAY, VENEZUELA.
The states and territories these words name
- District of Columbia
- Puerto Rico
They leave out North Dakota.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Apr 3, 2013.
- FDA classified it on Aug 28, 2013.
- FDA’s Enforcement Report published it on Sep 4, 2013.
- FDA terminated it on Jul 25, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 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 14, 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 246,231 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 14, 2026 and checked Oct 20, 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 20, 2026.