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205 results
FDA · FDA event 94988
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the…
Posted Aug 16, 2024
FDA · FDA event 94690
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Posted Aug 9, 2024
FDA · FDA event 94959
Improperly performed testing prior to release
Posted Aug 7, 2024
FDA · FDA event 94225
FDA record 206603 (Z-2419-2024), for CADD-Solis Model 2100, identifies eight issues in software before version 4.3: upstream occlusion; unresponsive Stop and Power keys; the manual-mode air detector; single-bubble air detection; error codes not appearing at…
Posted Aug 3, 2024
FDA · FDA event 93393
If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high…
Posted Jan 16, 2024
FDA · FDA event 93474
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to…
Posted Dec 20, 2023
FDA · FDA event 93106
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Posted Nov 7, 2023
FDA · FDA event 92909
An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in therapy. To reduce the…
Posted Sep 20, 2023
FDA · FDA event 92630
Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
Posted Aug 18, 2023
FDA · FDA event 92708
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2…
Posted Aug 17, 2023