Recall Z-1726-2025 · CBK Ventilator, Continuous, Facility Use
Baxter Healthcare Corporation
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
| Date | May 9, 2025 (initiated Apr 7, 2025) |
| Status | Open, Classified |
| Reason | A cybersecurity vulnerability was discovered through internal testing. |
| Root 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 opt |
| Quantity | 4174 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170037 | Breathe Technologies Life2000 Ventilation System Breathe Technologies, Aug 11, 2017 |