Class 1 Device Recall Welch Allyn Life2000

• Date Initiated by Firm: April 07, 2025
• Date Posted: May 09, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1726-2025
• Recall Event ID: 96611
• 510(K)Number: K170037
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
• Code Information: ALL SERIAL NUMBERS: 1) BT-80-0004, UDI/DI 00887761978041 or 00815410020292 or 00887761978072; 2) BT-80-0004A, UDI/DI 00887761978041 or 00815410020292 or 00887761978072; 3) BT-80-0008, UDI/DI 00887761976283; 4) BT-80-0008A, UDI/DI 00887761976283; 5) RMS010093CP, UDI/DI 00887761978041 or 00815410020537 or 00815410020292.
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: A cybersecurity vulnerability was discovered through internal testing.
• FDA Determined Cause: Software in the Use Environment
• Action: Baxter issued an URGENT MEDICAL DEVICE RECALL notice to healthcare providers and patients beginning on 04/07/2025 via USPS first class mail. The notice explained that Baxter was voluntarily initiating a permanent removal of all Life 2000 ventilators currently in use due to a cybersecurity issue and requested the following: Actions to be Taken by DME Providers: 1. Notify your patients using Life2000 ventilators of this recall. 2. Work with patients and prescribers to identify an alternate therapy option. 3. Contact Baxter Acute Care Customer Service team at 800-426-4224, option 2, then option 1, to coordinate return of Life2000 ventilators and compressors. Actions to be Taken by Healthcare Providers: 1. Locate and discontinue use of all Life2000 ventilators and compressors within your facility. 2. Contact Baxter Acute Care Customer Service team at 800-426-4224, option 2, then option 1, to coordinate return of Life2000 ventilators and compressors at your facility. Actions to be Taken by Distributors: 1. Please disseminate this information and conduct a user-level recall of the affected product that you distributed to customers. 2. Contact Baxter Acute Care Customer Service team at 800-426-4224, option 2, then option 1, to coordinate return of Life2000 ventilators and compressors. If you suspect that a device has been exposed to unauthorized personnel, contact Baxter Acute Care Customer Service team. The team can help verify whether the device settings are correct and if the device is performing as expected. The team can be reached by email at HRC_ACCS_Web@baxter.com, or by phone at 800-426-4224, option 2, then option 1. For questions regarding this communication, contact Baxter Acute Care Customer Service team at 800-426-4224, option 2, then option 1, between the hours of 8:00 am and 6:00 pm Central Time, Monday through Friday.
• Quantity in Commerce: 4174 units
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBK