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Terminated

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.

FDA Recall Z-1331-2014 · Posted 2014-04-03

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2014-03-07
Date Terminated2015-11-12
Product Quantity675

Reason for Recall

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.

Firm Action

Siemens sent an Customer Safety Advisory Notifications on March 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new version of software resolving this error will be provided free of charge. Your local Customer Service Engineer will contact you to schedule an appointment to make the necessary repairs on your system. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization who need to be aware of this issue. As always, patient safety issues are a high priority. To date, no patient injury has been reported. This problem was discovered as part of our ongoing quality process. For further questions please call (650) 694-5398. We sincerely regret any inconvenience this condition may cause in your daily operations.

Root Cause

Device Design

Distribution Pattern

Class II Recall - Worldwide Distribution - US Distribution and the countries of Australia, Austria, Belgium, Bhutan, Bolivia, Botswana, Bulgaria, Canada, Chile, Colombia, Croatia, Dem. Rep. Congo, Denmark, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Ivory Coast, Japan, Kuwait, Malaysia, Mauritius, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Saudi Arabia, Serbia, Seychelles, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad,Tobago, Turkey, U.A.E. and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121384MYLABSOGNOEsaote, S.p.A. · 2012-05-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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