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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0754-2023 - Vivid S5 N ultrasound. Not marketed in the US.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adul...
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2
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12/22/2022
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GE Medical Systems, LLC
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Z-0752-2023 - Vivid S5 Ultrasound.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adul...
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2
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12/22/2022
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GE Medical Systems, LLC
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Z-0755-2023 - Vivid S6 N ultrasound. Not marketed in the US.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adul...
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2
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12/22/2022
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GE Medical Systems, LLC
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Z-0753-2023 - Vivid S6 ultrasound.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adul...
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2
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12/22/2022
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GE Medical Systems, LLC
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Z-0758-2023 - Vivid i N ultrasound. Not marketed in the US.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult...
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2
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12/22/2022
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GE Medical Systems, LLC
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Z-0756-2023 - Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062).
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; ...
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2
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12/22/2022
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GE Medical Systems, LLC
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Z-0759-2023 - Vivid q N ultrasound. Not marketed in the US.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adu...
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2
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12/22/2022
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GE Medical Systems, LLC
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Z-0757-2023 - Vivid q ultrasound.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult...
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2
|
12/22/2022
|
GE Medical Systems, LLC
|