Recall Z-0198-2023— Canon Medical System, USA, INC.
Class II · Ongoing
Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2022-09-29. It names 2 FDA 510(k) clearances: K212960, K212333. Product: Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450. Reason: After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay..
- Recalling firm
- Canon Medical System, USA, INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-29
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K212960 — Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
- K212333 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450
Reason for recall
After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.
Data sourced from openFDA. This site is unofficial and independent of the FDA.