Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides

FDA device recall Z-1331-2014 · posted 2014-04-03 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

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.

Action taken

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

Status

Terminated

Product code

IYN

Quantity affected

675

Distribution

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, Den

Date initiated

2014-03-07

Date posted

2014-04-03

Date terminated

2015-11-12

Location

Mountain View, CA

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