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
