Important Product Updates

Important Product Updates

Product Updates

This page houses important updates about our products and therapies. Information regarding the product updates on this page has been provided directly to impacted customers, as applicable, with respect to open product related matters.

 

Date Product Category Reference
7/14/25 Novum IQ LVP Urgent Medical Device Recall

Important safety information regarding the potential for underinfusion following specific rate changes and the potential for over or underinfusion due to set misloading

Customer Letter 7/14/25

FDA Announcement

6/20/25 Sigma Spectrum Infusion System (V6 and V8 Platforms) Urgent Medical Device Correction

Important Safety Information regarding the potential for certain Spectrum infusion pumps to have received an incorrect software version

Customer Letter 6/20/25

FDA Announcement

05/30/25 Q-link 13 lift component and LikoScale adapter kit Urgent Product Recall

Important safety information regarding the possibility of improper attachment (false latching) of the quick-release hook used on sling bars and other accessories.

Customer Letter 5/30/25

FDA Announcement

4/24/25 Novum IQ LVP Urgent Medical Device Correction

Important Safety Information regarding the potential for under infusion following use of the “standby mode” feature, or if the device is powered off with the set loaded.

Customer Letter 4/24/25

FDA Announcement

4/10/25 Life2000 Ventilation System Urgent Product Recall

Permanent removal of device due to cybersecurity issue

Customer Letter 4/10/25

FDA Announcement

2/5/25 Sigma Spectrum Infusion System V6 Platform and Spectrum IQ Infusion System with Dose IQ safety Software Urgent Medical Device Recall

Important safety information regarding the potential for missing motor mounting screws, which may have occurred during the servicing process

Customer Letter 2/5/25

FDA Announcement

12/20/24 Life2000 Ventilation System Urgent Medical Device Correction

Important safety information regarding an issue with the ventilator battery charger

Customer letter 12/20/24

Home patient letter 12/20/24

FDA Announcement

9/12/24 Life2000 Ventilation System Urgent Medical Device Correction

Important safety information regarding ventilator failure to initiate low gas pressure alarm

Customer letter 9/12/24

Home patient letter 9/12/24

FDA Announcement

8/20/24 Automated Compounding Device Inlets (disposable inlet) used with the ExactaMix and ExactaMix Pro Urgent Medical Device Correction

Important Safety Information regarding the potential presence of particulate matter within the inlet primary packaging components, including within the sterile fluid path tubing

Customer letter 10/18/24

Customer letter 8/20/24

FDA Announcement

5/30/24 Volara System Urgent Medical Device Recall

Important safety information regarding potential for the handset plug to disconnect from the nebulizer port on the blue ventilator adapter

Customer letter 5/30/24

Home patient letter 5/30/24

FDA Announcement

5/29/24 Life2000 Ventilation System Urgent Medical Device Recall

Important safety information regarding failure to charge or intermittent charging due to damage to battery charger dongle

Home patient letter 5/29/24

FDA Announcement

1/25/23
10/3/24
Life2000 Ventilation System Urgent Medical Device Correction

Important Safety Information regarding the potential for patient oxygen desaturation events that can occur when Life2000 system is connected with a third-party oxygen concentrator

Customer letter 1/25/23

Home patient letter 1/25/23

Customer letter 10/3/24

Home patient letter 10/3/24

FDA Announcement

12/29/21
6/15/23
Spectrum IQ Infusion System with Dose IQ Safety Software SIGMA Spectrum Infusion System (V8 Platform) Urgent Safety Communication

Important Safety Information regarding upstream occlusion alarms for all Spectrum IQ and Spectrum V8 infusion pumps

Customer Letter 6/15/2023

Customer Letter 12/29/2021

FDA Announcement