Reported Apr 7, 2021 · Ongoing
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual…
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?
- Product Label - ACUSON Sequoia ***
- Power Input100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
- Lot codes and dates
- Model11148775 Equipment Serial Numbers (U.S.)Equipment Serial Numbers (O.U.S.):
614 of 614 codes
800015800101800103800104800105800106800107800108800109800111800112800113800116800118800119800121800134800138800139800141800142800143800149800150800151800152800153800155800157800158800161800165800168800172800174800175800176800177800178800182800183800184800185800186800189800190800191800192800193800194800195800196800198800199800201800203800204800205800208800209
558 of 558 codes
800344800438800932801787801851801020801927801982801988802069802073802078802079802081802083802084802086802123802131802135802140802147802180802181802183802185802186802187802188802189800114800115800117800120800122800123800126800127800129800130800133800135800136800140800147800148800159800162800163800166800167800169800170800171800181800187800197800206800207800212
- Model11148775 Equipment Serial Numbers (U.S.)
- Amount recalled
- 1,172 systems
Where it was sold
Why it was recalled
The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.
This product could cause temporary or reversible health problems — stop using it.
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