Class I - Dangerous
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
TURBETT SURGICAL
Class I - Dangerous
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
Class I - Dangerous
Devices were subject to unapproved rework processes.
Class I - Dangerous
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.