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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:209873

ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software

Official recall number

Z-3217-2024

Evidence summary

Product code
IYN
Recall status
Open, Classified
Event initiated
August 15, 2024
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-3217-2024

Field note

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