Reported May 1, 2024 · Ongoing
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 22010 Se 51st St · Issaquah, WA · 98029-7298
Is this the product you have?
- ACUSON Maple Diagnostic Ultrasound System
- REF11711750, ACUSON Maple Select
- REF
11711779running software version VA10A
- Lot codes and dates
- REF/UDI-DI
11711750/04056869995809and 11711779/04056869995830
- Serial Numbers
67 of 67 codes
700127700125700109700123700124700126700131700077700081700070700071700073700075700076700072700074700096700097700098700100700103700082700030700036700037700028700029700031700033700022700023700024700025700035700121700111700132700065700058700026700019700020900581900582900583900585700034700032700041700040700039700052700053700057700038700063700062700060700064700068
- REF/UDI-DI
- Amount recalled
- 67
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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