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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:185877

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

Official recall number

Z-1330-2021

Evidence summary

Product code
IYN
Recall status
Open, Classified
Event initiated
February 04, 2021
Root cause
Software Design Change
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1330-2021