Reported Dec 7, 2016 · Terminated
Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON…
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?
- Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113
- RadiologyThe ACUSON SC2000 ultrasound imaging system is
- intended for the following applicationsCardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Neurological-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctive with other medical data obtained by a physician for clinical diagnosis purposes
- Lot codes and dates
- Model number 10436113 -Z6Ms Transesophageal tranducer
- US Serial numbers
632290076322900863432010635305186332200763230009632605846353051663432007633190126333200463325007633280036332800763332002630290156332901763230003
- Foreign serial numbers
632605856323000263029009633290186322901163432015632290126343052463029016633606116336061263432017
- Amount recalled
- 33
Where it was sold
- Nationwide
Why it was recalled
Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
This product could cause temporary or reversible health problems — stop using it.
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