FDANovember 7, 2016device
Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, A...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
What to do
FDA enforcement status: Terminated
Brands named
siemens medical solutionssiemenssiemens medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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