Recall Z-1601-2024— Siemens Medical Solutions USA, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2024-02-23. It names one FDA 510(k) clearance: K232617. 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-23
- Firm location
- Issaquah, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.