GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide…
Medical device recall Z-0747-2014. Published in FDA’s Enforcement Report on Jan 22, 2014.
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 Jan 22, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 42 states named
- 43,033 (25,681 USA; 17,352 OUS) 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 failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Carescape Patient Data Module 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.
43,033 (25,681 USA; 17,352 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # SA307140598GA SA307140599GA SA307140600GA SA307140601GA SA307140605GA SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140612GA SA307140614GA SA307140615GA SA307140618GA SA307140619GA SA307140622GA…
Every code shown here, 1,994 characters
Mfg Lot or Serial # SA307140598GA SA307140599GA SA307140600GA SA307140601GA SA307140605GA SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140612GA SA307140614GA SA307140615GA SA307140618GA SA307140619GA SA307140622GA SA307140623GA SA307140627GA SA307140628GA SA307140631GA SA307140632GA SA307140636GA SA307140637GA SA307140639GA SA307140640GA SA307140641GA SA307140642GA SA307140644GA SA307150645GA SA307150646GA SA307150655GA SA307150656GA SA307020391GA SA307030405GA SA307030424GA SA307070446GA SA307070447GA SA307070448GA SA307080462GA SA307080463GA SA307080484GA SA307080508GA SA307080523GA SA307110548GA SA307110556GA SA307110571GA SA307190716GA SA307190737GA SA307190739GA SA307190750GA SA307190768GA SA307020379GA SA307020384GA SA307020386GA SA307030407GA SA307030409GA SA307030412GA SA307030414GA SA307060432GA SA307070436GA SA307070440GA SA307070441GA SA307070442GA SA307070450GA SA307070453GA SA307070454GA SA307070455GA SA307080472GA SA307080477GA SA307080478GA SA307080504GA SA307080520GA SA307080526GA SA307110559GA SA307110560GA SA307110572GA SA307110575GA SA307110579GA SA307120587GA SA307120588GA SA307150681GA SA307180694GA SA307180696GA SA307180697GA SA307190717GA SA307190718GA SA307190720GA SA307190722GA SA307190724GA SA307190727GA SA307190728GA SA307190729GA SA307190730GA SA307190732GA SA307190733GA SA307190734GA SA307190738GA SA307190741GA SA307190742GA SA307190743GA SA307190744GA SA307190745GA SA307190749GA SA307190764GA SA307190766GA SA307190769GA SA307190770GA SA307190771GA SA307020383GA SA307030411GA SA307030413GA SA307050429GA SA307070443GA SA307080459GA SA307080467GA SA307080521GA SA307080522GA SA307080524GA SA307150651GA SA307180699GA SA307190736GA SA307190755GA SA307190773GA SA307190774GA SA307200784GA SA307220983GA SA307221081GA SA307221089GA SA307020393GA SA307020396GA SA307020397GA SA307020399GA SA307030417GA SA307030419GA SA307030423GA SA307070438GA SA307080473GA SA307080493GA SA307080498GA SA307080499GA SA307080509GA SA307080510GA…
FDA’s list runs to 643,664 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: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN, MS, NO, NE, NV, NJ, NM, NY, NC, OH, OK,OR, PA, RI, SC, TN, TX, UT,VT, VA, WA, WI, and WY. Internationally to: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Egypt,England, Estonia, Finland,France, Germany,Greece, Guatemala, Hungary,India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates and United Kingdom.
The states and territories these words name
42 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Mississippi
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- Wyoming
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 Nov 27, 2013.
- FDA classified it on Jan 14, 2014.
- FDA’s Enforcement Report published it on Jan 22, 2014.
- FDA terminated it on Sep 7, 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 643,664 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.