Aug

2001

INC ClassII SONOSITE

Company: SONOSITE, INC
Date of Enforcement Report: 8/22/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-868-1, Sonosite 180 – portable, software controlled ultrasound system intended for use with a variety of transducers to perform a variety of scans and measurements/calculations for the abdomen, pediatric scans, general cardiac, GYN/infertility, obstetrics. Code: Sonosite units with the following software versions: 01.xx.003.00 to 01.xx.003.067 and 01.xx.002.yyy and 01.xx.001.yyyxx is 40, 60, or 80; and yyy is 000 through 999

REASON:
POTENTIAL FOR MISCALCULATION OF ESTIMATED DELIVERY DATE

MANUFACTURER/RECALLING FIRM:
SONOSITE, INC., Bothell, WA

RECALLED BY:
The firm notified customers in a letter dated 5/4/00.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide and worldwide
Military distribution: Bremerton Naval Hospital, Bremerton, WA.

QUANTITY:
1,026 units

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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INC ClassII SONOSITE

Amy Sellers

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