Reason: Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.
Distributed: Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.Reason: Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
Distributed: Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, Korea, New Zealand, Taiwan, Thailand, France, Germany, Ireland, Netherlands, Italy, Spain, Turkey, United Kingdom, Chile, and Colombia.Reason: Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
Distributed: US Nationwide distribution.Reason: Product lacks 510(k) clearance.
Distributed: US Nationwide distribution.Reason: Product lacks 510(k) clearance.
Distributed: US Nationwide distribution.Reason: Product lacks 510(k) clearance.
Distributed: US Nationwide distribution.Reason: Product lacks 510(k) clearance.
Distributed: US Nationwide distribution.Reason: Product lacks 510(k) clearance.
Distributed: US Nationwide distribution.Reason: Product lacks 510(k) clearance.
Distributed: US Nationwide distribution.Reason: Product lacks 510(k) clearance.
Distributed: US Nationwide distribution.