FDA Device recall Z-1833-2013
GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system
- FDA Device
- Class II
- terminated
- Published 2013-08-07
On 2013-08-07 the FDA classified a Class II recall of GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system by Ge Healthcare, citing 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 fre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1833-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-13 |
| Published | 2013-08-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | AK, AR, AZ, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NC, NE, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, WI |
Product
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).
Reason
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.
Identifiers
| code_info | Mfg Lot or Serial # D16290 D16293 D16294 D16295 D16296 D16297 D16299 D16300 D16301 D16302 D16303 D16304…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 D |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1833-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.