Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 9, 2014
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.
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 temperatur…
Siemens Medical Solutions USA, Inc. recalled Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe… - a moderate-severity action.
Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe… was recalled by Siemens Medical Solutions USA, Inc. in April 9, 2014. Reason: ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% …. Check the official notice for the remedy. Verify recall #Z-1331-2014 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc. issued this moderate-severity FDA Devices recall-ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% ….
- Moderate
- severity level
- 675 units
- affected scope
- Class II
- classification
- April 9, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1331-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1331-2014) was formally reported on April 9, 2014, with the manufacturer initiating the action on March 7, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Medical Solutions USA, Inc. is listed as the recalling firm, operating out of Mountain View, CA. Federal records list the affected scope as 675.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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, Fran…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
675
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1331-2014 |
| Date reported | April 9, 2014 |
| Date initiated | March 7, 2014 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Firm location | Mountain View, CA |
| Affected scope | 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, Denmark, Ecuador, France, Germany, Greece,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1331-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 675.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2014. Severity: Moderate. Recall number: Z-1331-2014.
Where was the recalled product distributed? ▼
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, 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1331-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 9, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.