Siemens Recalls Z6Ms Transesophageal Transducers Due to Material Deterioration
Siemens is recalling 33 Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems because the material covering the articulating section has deteriorated, causing acquisition errors.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard involves material deterioration and acquisition errors, which fits the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 33 Z6Ms transesophageal transducers (model 10436113) used on ACUSON SC2000 ultrasound systems. The recall was initiated after the firm received reports of "acquisition errors" and the deterioration of the material covering the articulating section of the transducer.
The affected devices were distributed nationwide in the United States and internationally to Austria, Germany, South Africa, the Netherlands, Mauritius, Mexico, Italy, Japan, and Sweden. Specific US and foreign serial numbers for the 33 units are listed in the official recall documentation.
Healthcare facilities should stop using the affected transducers and contact Siemens Medical Solutions USA, Inc. for instructions on repair or replacement. Patients who have undergone imaging with these devices should consult their physician if they have concerns about the accuracy of their results.
The recalled product
- Product
- 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,
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 33
Distribution
Distributed nationwide across the United States.
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