Reported Aug 5, 2015 · Terminated
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 685 E Middlefield Rd · Mountain View, CA · 94043-4045
Is this the product you have?
- ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option
- Model numbers10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ
- Option- 10439521 and 10439522 RadiologyThe ultrasound imaging systems are
- intended for the following applicationsFetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications
- Lot codes and dates
- Model numbers
1004146110440017 - S2000 system10441730 - S3000 systemVTIQ Option - 10439521 and 10439522
- Serial numbers for US
169 of 169 codes
210104211147211148210257211071201387201389206511206574206592206619206732206832208718208772210931211483212156212157202555210055210061210423210426210427210629206049210032210128210334210361211742211334211156211165211215211180211183208220210666211158211338211425211611212064211091210343203158211278210692210748210777210010210479211550211551205213211123211448211709
- Serial numbers for ROW
460 of 460 codes
211768210671211803212186206153206181210340210752210763211060211182211351211705210494210935207083207298207553208176203090203106206480210105210725210799211059211262210064202134203148203282203549205242205260205381206678206756206819206857207988209048209088209120211085211397206341210085211432211445210144210225210620210793211178207878210218210707210718211041208127
- Model numbers
- Amount recalled
- 629 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Medical Solutions USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.