PlainRecalls
FDA Devices Moderate Class II Terminated

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, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Neurological-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure a

Reported: December 7, 2016 Initiated: November 7, 2016 #Z-0667-2017

Product Description

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, 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.

Reason for Recall

Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.

Details

Units Affected
33
Distribution
Worldwide Distribution - US (nationwide) Internationally to AUSTRIA, GERMANY, SOUTH AFRICA, NETHERLANDS, MAURITIUS, MEXICO, and ITALY, JAPAN, SWEDEN
Location
Mountain View, CA

Frequently Asked Questions

What product was recalled? ▼
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, 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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 33.
Why was this product recalled? ▼
Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0667-2017.

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