GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
Medical device recall Z-1833-2013. Published in FDA’s Enforcement Report on Aug 7, 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 7, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 30 states named in where it went
- 375 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 that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a certain workflow. This issue can be resolved by rebooting the system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).
375, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # D16290 D16293 D16294 D16295 D16296 D16297 D16299 D16300 D16301 D16302 D16303 D16304 D16305 D16306 D16309 D16310 D16311 D16312 D16313 D16314 D16315 D16316 D16318 D16319 D16326 D16335 D16336 D16337 D16338 D16339 D16340…
Every code shown here, 1,994 characters
Mfg Lot or Serial # D16290 D16293 D16294 D16295 D16296 D16297 D16299 D16300 D16301 D16302 D16303 D16304 D16305 D16306 D16309 D16310 D16311 D16312 D16313 D16314 D16315 D16316 D16318 D16319 D16326 D16335 D16336 D16337 D16338 D16339 D16340 D16341 D16342 D16343 D16345 D16346 D16362 D16366 D16367 D16368 D16370 D16371 D16372 D16373 D16374 D16375 D16377 D16378 D16396 D16398 D16399 D16400 D16401 D16402 D16403 D16404 D16405 D16406 D16432 D16433 D16434 D16435 D16436 D16437 D16438 D16439 D16440 D16441 D16453 D16458 D16460 D16461 D16462 D16466 D16467 D16468 D55513 D55514 D55515 D55519 D55520 D55521 D55522 D55538 D55539 D55540 D55541 D55543 D55549 D55550 D55551 D55565 D55566 D55568 D55578 D55579 D55580 D55581 D55582 D55598 D55603 D55605 D55606 D55615 D55616 D55617 D16407 D55524 D04446 D16477 D55516 D55534 D55557 D55588 D16239 D55576 D55623 D55625 D16348 D16349 D16350 D55552 D55553 D55554 D55555 D55560 D16254 D16257 D16257 D55336 D55337 D55338 D55348 D55595 D13829 D15232 D15425 D15973 D16193 D16245 D16248 D16255 D16260 D16262 D16317 D16324 D16334 D16344 D16352 D16358 D16369 D16380 D16384 D16385 D16390 D16393 D16424 D16445 D16448 D16454 D16455 D16464 D16480 D16481 D16482 D16483 D16484 D16486 D16487 D55437 D55517 D55548 D55575 D55593 D55607 D55608 D55611 D55612 D55621 D55624 D55627 D16240 D55518 D55572 D55573 D55574 D55610 D16442 D55510 D55599 D55622 D03382 D16256 D55544 D55629 D05257 D10516 D13472 D15189 D15444 D15454 D16235 D16242 D16244 D16246 D16251 D16264 D16265 D16277 D16279 D16280 D16281 D16284 D16331 D16333 D16347 D16353 D16382 D16387 D16388 D16389 D16409 D16410 D16411 D16412 D16413 D16414 D16415 D16427 D16428 D16429 D16443 D16444 D16449 D16478 D55532 D55556 D55585 D55586 D55587 D00716 D04334 D11004 D15447 D16241 D16258 D16263 D16276 D16286 D16287 D16289 D16291 D16292 D16307 D16327 D16379 D16391 D16408 D16416 D16423 D16425 D16426 D16430 D16488 D55015 D55472 D55525 D55526 D55527 D55528 D55530 D55535 D55542 D55545 D55567 D55589 D55590 D55591 D55592 D55596 D55597 D55632…
FDA’s list runs to 2,644 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 Distribution including the states AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NE, NV, NM, NY, NC, OH, OR, PA, SC, SD, TN,TX, VA, WA and WI., and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRIL, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF MOLDOVA, NETHERLANDS, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, KINGDOM OF SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA.
The states and territories these words name
30 states and territories.
Every one of them
- Alaska
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Illinois
- Louisiana
- Maryland
- Michigan
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 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 Jul 13, 2012.
- FDA classified it on Jul 31, 2013.
- FDA’s Enforcement Report published it on Aug 7, 2013.
- FDA terminated it on Nov 10, 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 2,644 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.