June 6, 2025

Jun

FDA Recall: Incorrect software logic may cause frequent E1 errors

June 6, 2025Allison PateNews

Company: Cardinal Health 200, LLC Date of Enforcement Report: 6/6/2025 Class: II PRODUCT SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Recall Number: Z-1917-2025 REASON: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or...

Jun

FDA Recall: Unreleased software versions were installed on distributed devices without verification or validation

June 6, 2025Allison PateNews

Company: Zyno Medical LLC Date of Enforcement Report: 6/6/2025 Class: I PRODUCT Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Recall Number: Z-1865-2025 REASON: Unreleased software versions were installed on distributed devices without verification or validation. RECALLING FIRM/MANUFACTURER: Zyno Medical LLC VOLUME: 613 units DISTRIBUTION:...

FDA Recall: Incorrect software logic may cause frequent E1 errors

FDA Recall: Unreleased software versions were installed on distributed devices without verification or validation

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FDA Recall: Incorrect software logic may cause frequent E1 errors

FDA Recall: Unreleased software versions were installed on distributed devices without verification or validation

Upcoming Public Courses

Corporate Office