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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recalls |
|---|---|
| Recall Numbers | Z-1599-2024 (Juniper), Z-1600-2024 (Redwood), Z-1601-2024 (Maple) |
| Risk Class | Class 2 |
| Recall Qty | 5785 (total) |
| Classification Date | 2024-04-19 |
| Recall Link | Recall Link. Enter search terms: Product: acuson Recall Date from: 4/19/2024 Recall Date to: 4/19/2024 Firm: Siemens |
| Notes/Alerts | Systems Not Affected: 1). ACUSON Juniper Ultrasound System, product version 2.5, software version VB30D. 2). ACUSON Redwood system, product version 2.0. |
| Recall Reason | When Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max. |
DEVICE
| Manufacturer | Siemens Medical Solutions USA, Inc. |
|---|---|
| Model Names | ACUSON Juniper, Juniper Select, Redwood, Maple, and Maple Select |
| Model Numbers | 11335791, 11653093, 11503314, 11711750, 11711779 |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | ACUSON Juniper, Juniper Select, Redwood, Maple, and Maple Select Diagnostic Ultrasound Systems |
| Serial Number(s) | +5700 |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
1. On 2/23/24, correction notices were sent to customers informing them of the following: This issue is specific to and limited to the use of the Cardiac DICOM SR feature:
2. – When a user uses and configures the Cardiac DICOM SR feature to display either the MINIMUM (Min) or the MAXIMUM (Max) measured value, AND
– Makes multiple measurements of the cardiac region during an examination, AND
– Exports the results into the Cardiac DICOM SR feature, THEN
– The Cardiac DICOM SR viewer will NOT display the MINIMUM (Min) or MAXIMUM (Max) value and will instead display the LAST measured value. In that case, the displayed measurement in the Cardiac DICOM SR viewer may NOT be the Minimum (Min) or MAXIMUM (Max) value measured during the examination.
3. To avoid potential misdiagnosis by an over- or underrepresented measured value, it is recommended to refer to the measurement values displayed on the Ultrasound System Final Report when the configuration is to display the Min or Max value. Firm recommends a review of previous cardiac ultrasound examination results where the clinical assessment was reviewed using a DICOM SR viewer.
4. Your Customer Service Engineer from will contact you to schedule a facility visit to update the system or inform you of a remote update when the software update is available. The software update is currently under development and estimated to be available by spring/summer of 2024.
5. Please ensure that all users of the affected devices within your organization, and others who may need to be informed, receive the safety relevant information provided with this notice and take the actions specified herein. If you have further questions, please contact the firm’s Ultrasound Service Customer Care Center at 1-800-888-7436.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to Siemens. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
