FDA Device recall Z-1601-2024
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A by Siemens Medical Solutions Usa, citing on ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and resu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1601-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-23 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Reason
On ultrasound systems, 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, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Identifiers
| code_info | REF/UDI-DI: 11711750/04056869995809, and 11711779/04056869995830. Serial Numbers: 700127 700125 700109 700123 700124 70…REF/UDI-DI: 11711750/04056869995809, and 11711779/04056869995830. Serial Numbers: 700127 700125 700109 700123 700124 700126 700131 700077 700081 700070 700071 700073 700075 700076 700072 700074 700096 700097 700098 700100 700103 700082 700030 700036 700037 700028 700029 700031 700033 700022 700023 700024 700025 700035 700121 700111 700132 700065 700058 700026 700019 700020 900581 900582 900583 900585 700034 700032 700041 700040 700039 700052 700053 700057 700038 700063 700062 700060 700064 700068 700059 700084 700083 700107 700114 700115 700135. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1601-2024%22
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