Reported Aug 5, 2015 · Terminated
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model…
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 S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1
- Model numbers10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701
- S 1000 system 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 numbers10041461, 10440017 S2000 system 10441730 S3000 system 10441701 S1000 system; software version VC30A, VC30B, VC30C, or VC31A
- Serial numbers US
660 of 660 codes
210104210121210187211161210103206479206595206701206726200313200394207073207099210186210811211030211147211148211477212130210509210510210540210702210714210911210957211031211097211259211368211441211444211454211511211612211689211694210172210173210178210188210257211439211071211438211453211459200245201227201256201387201389206039208718208772210112210229210260210689
- Serial numbers ROW
1,129 of 1,129 codes
211768210266200660202046202180202730205504206488207116207357210074210081210168210206210511210576210630210671210803210805210829210846210994210996211001211004211014211076211164211166211392211473211569211792211803211804212186212237210363210368210415210553210558210852210987211119211206203419207770210110210253210340210456210524210752210763210991211055211060211182
- Amount recalled
- 1789 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
- PR
Why it was recalled
Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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