GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for…
Medical device recall Z-1944-2013. Published in FDA’s Enforcement Report on Aug 21, 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 Aug 21, 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 32 states named
- 755 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 a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or Time Intensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume, Depth measur
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
755, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # 171947SU5 176566SU8 176567SU6 179458SU5 182385SU5 182653SU6 182654SU4 182656SU9 164236SU2 173818SU6 172242SU0 172243SU8 176260SU8 180632SU2 181231SU2 181232SU0 181233SU8 181234SU6 181235SU3 158763SU3 158799SU7 159780SU6…
Every code shown here, 2,000 characters
Mfg Lot or Serial # 171947SU5 176566SU8 176567SU6 179458SU5 182385SU5 182653SU6 182654SU4 182656SU9 164236SU2 173818SU6 172242SU0 172243SU8 176260SU8 180632SU2 181231SU2 181232SU0 181233SU8 181234SU6 181235SU3 158763SU3 158799SU7 159780SU6 163222SU3 165600SU8 168075SU0 169495SU9 170681SU1 170893SU2 171937SU6 171941SU8 171943SU4 176123SU8 176125SU3 176129SU5 177080SU9 178951SU0 180108SU3 180110SU9 180763SU5 180766SU8 182661SU9 182379SU8 176132SU9 159604SU8 159766SU5 158247SU7 172656SU1 161686SU1 170273SU7 170272SU9 170274SU5 176924SU9 159768SU1 170197SU8 171541SU6 171540SU8 171542SU4 164268SU5 166218SU8 171371SU8 168779SU7 167274SU0 171369SU2 177085SU8 177084SU1 171370SU0 168788SU8 178593SU0 178594SU8 178595SU5 176926SU4 176925SU6 158248SU5 159963SU8 160741SU5 160742SU3 160743SU1 159964SU6 178592SU2 159965SU3 159767SU3 181434SU2 166181SU8 183107SU2 169509SU7 159792SU1 183118SU9 170672SU0 176130SU3 182380SU6 158768SU2 159776SU4 182223SU8 182222SU0 183104SU9 166172SU7 170671SU2 168080SU0 182655SU1 183102SU3 183907SU5 176939SU7 180973SU0 176938SU9 183660SU0 183661SU8 180363SU4 159246SU8 158802SU9 158805SU2 180762SU7 170669SU6 170679SU5 170683SU7 162595SU3 162592SU0 170670SU4 183108SU0 168064SU4 169487SU6 169506SU3 176121SU2 158806SU0 178022SU0 159784SU8 165587SU7 168058SU6 170676SU1 163224SU9 159789SU7 182227SU9 178023SU8 165585SU1 168056SU0 182228SU7 182376SU4 168063SU6 183105SU6 168068SU5 170675SU3 168069SU3 165588SU5 175622SU0 175623SU8 168070SU1 180761SU9 182382SU2 176136SU0 159782SU2 159783SU0 168057SU8 182230SU3 183106SU4 182378SU0 168060SU2 163225SU6 183109SU8 183110SU6 168059SU4 166185SU9 159788SU9 178018SU8 170674SU6 161687SU9 161688SU7 161689SU5 161690SU3 161691SU1 161692SU9 162593SU8 162594SU6 165584SU4 176135SU2 165583SU6 165586SU9 182377SU2 158800SU3 159793SU9 159951SU3 168074SU3 170892SU4 171944SU2 162596SU1 168071SU9 175624SU6 178027SU9 181605SU7 166178SU4 183120SU5 178026SU1 171946SU7 182224SU6 170897SU3 168073SU5 178016SU2 169502SU2 169508SU9 178029SU5…
FDA’s list runs to 7,569 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, CA, CO, CT, DC, FL, GA, IL, IN, IA, LA, MA, MI, MS, MO, MT, NE, NV, NJ, NY, NC, OH, OK, PA,RI, SC, TN, TX, VA, WA, and WI; and countries of: ALGERIA, AUSTRALIA, AUSTRIA, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, LATVIA, LEBANON, MALAYSIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, REPUBLIC OF MOLDOVIA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and YUGOSLAVIA.
The states and territories these words name
32 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Louisiana
- Massachusetts
- Michigan
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
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 Aug 13, 2012.
- FDA classified it on Aug 9, 2013.
- FDA’s Enforcement Report published it on Aug 21, 2013.
- FDA terminated it on Sep 15, 2014.
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: Visit.
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 7,569 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
-
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.