This page contains 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
6/16/26
Product
ENVELLA Air Fluidized Therapy System
Category
Product Safety Information Letter
Reference
Important Safety Information due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Date
5/21/26
Product
VOLARA System
Category
Urgent Medical Device Correction
Reference
Important Safety Information due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Date
8/4/25
Product
NOVUM IQ Large Volume Pump (LVP) and NOVUM IQ Syringe Pump (SP)
Category
Urgent Medical Device Correction
Reference
Important Safety Information due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Date
7/14/25
Product
NOVUM IQ LVP
Category
Urgent Medical Device Recall
Reference
Important safety information regarding the potential for underinfusion following specific rate changes and the potential for over or underinfusion due to set misloading.
Date
6/20/25
Product
SIGMA SPECTRUM Infusion System (V6 and V8 Platforms)
Category
Urgent Medical Device Correction
Reference
Important Safety Information regarding the potential for certain SPECTRUM infusion pumps to have received an incorrect software version.
Date
5/30/25
Product
Q-link 13 lift component and LIKOSCALE adapter kit
Category
Urgent Product Recall
Reference
Important safety information regarding the possibility of improper attachment (false latching) of the quick-release hook used on sling bars and other accessories.
Date
4/24/25
Product
NOVUM IQ LVP
Category
Urgent Medical Device Correction
Reference
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.
Date
4/10/25
Product
LIFE2000 Ventilation System
Category
Urgent Product Recall
Reference
Permanent removal of device due to cybersecurity issue.
Date
2/5/25
Product
SIGMA SPECTRUM Infusion System V6 Platform and SPECTRUM IQ Infusion System with Dose IQ safety Software
Category
Urgent Medical Device Correction
Reference
Important safety information regarding the potential for missing motor mounting screws, which may have occurred during the servicing process.
Date
12/20/24
Product
LIFE2000 Ventilation System
Category
Urgent Medical Device Recall
Reference
Important safety information regarding an issue with the ventilator battery charger
Date
9/12/24
Product
LIFE2000 Ventilation System
Category
Urgent Medical Device Correction
Reference
Important safety information regarding ventilator failure to initiate low gas pressure alarm.
Date
8/20/24
Product
Automated Compounding Device Inlets (disposable inlet) used with the EXACTAMIX and EXACTAMIX PRO
Category
Urgent Medical Device Correction
Reference
Important Safety Information regarding the potential presence of particulate matter within the inlet primary packaging components, including within the sterile fluid path tubing.
Date
5/30/24
Product
VOLARA System
Category
Urgent Medical Device Recall
Reference
Important safety information regarding potential for the handset plug to disconnect from the nebulizer port on the blue ventilator adapter.
Date
5/29/24
Product
LIFE2000 Ventilation System
Category
Urgent Medical Device Recall
Reference
Important safety information regarding failure to charge or intermittent charging due to damage to battery charger dongle.
Date
1/25/23
10/3/24
Product
LIFE2000 Ventilation System
Category
Urgent Medical Device Correction
Reference
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.
Date
12/29/21
6/15/23
Product
SPECTRUM IQ Infusion System with Dose IQ Safety Software SIGMA SPECTRUM Infusion System (V8 Platform)
Category
Urgent Safety Communication
Reference
Important Safety Information regarding upstream occlusion alarms for all SPECTRUM IQ and SPECTRUM V8 infusion pumps.
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