FDA Device recall Z-1081-2013
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200
- FDA Device
- Class II
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class II recall of Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200 by Siemens Medical Solutions Usa, citing when using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1081-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-28 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-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 adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Reason
When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients.
Identifiers
| code_info | All units of this model. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1081-2013%22
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