Reported Apr 9, 2014 · Terminated
Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348).…
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?
- Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
- Lot codes and dates
- Model number 10433816 - ACUSON P3000 Ultrasound System; Model numbers 10852384 - P300 PA 320E transducer
- Serial numbers
675 of 675 codes
105106114116117118119120121122123124125126127128129130131132133134135136137138139140141142143144145146148149150152153154155156157158159160161162163164165166167168169170171172173174
- Amount recalled
- 675
Why it was recalled
ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maximum allowable limit.
This product could cause temporary or reversible health problems — stop using it.
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