Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
Baxter Healthcare Corporation · A cybersecurity vulnerability was discovered through internal testing.
Open FDA's page for this record- Cfres ID
- 213250
- Product res number
- Z-1726-2025
- Event date initiated
- 2025-04-07
- Event date posted
- 2025-05-09
- Recall status
- Open, Classified
- Res event number
- 96611
- Product code
- CBK
- Product description
- Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
- Firm FEI number
- 1417572
- Recalling firm
- Baxter Healthcare Corporation
- Address 1
- 1 Baxter Pkwy
- City
- Deerfield
- State
- IL
- Postal code
- 60015-4625
- Additional info contact
- Center for One Baxter 800-422-9837
- Reason for recall
- A cybersecurity vulnerability was discovered through internal testing.
- Root cause description
- Software in the Use Environment
- Product quantity
- 4174 units
- Distribution pattern
- Worldwide distribution.
- Code info
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.
- 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.
- K numbers
- K170037
- Harmonized identifiers (openFDA)
- Device name
- Ventilator, Continuous, Facility Use
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5895
- Device class
- 2
- K number
- K880721, K972248, K900465, K926292, K130171, K844590, K813253, K081845, K892886, K982174, K896736, K850374, K001686, K232365, K141943, K213098, K083526, K043085, K092148, K870861, K871398, K812980, K790605, K112729, K871985, K961687, K011957, K840345, K896735, K010093, K863228, K790732, K081670, K913972, K970460, K843737, K924930, K911336, K032226, K822233 +465 more
- Registration number
- 8021084, 2024500, 2085602, 3003135857, 3005783425, 3017520736, 1924066, 3016723884, 3003908598, 3010157426, 3010882708, 3029871637, 3008264065, 1316463, 3002797442, 3009129579, 1625392, 2021710, 9617566, 3014766741, 3003862188, 3021947238, 1218058, 3008496839, 3011213495, 1222088, 3032026475, 3009302812, 9615827, 3021244152, 3044156918, 3004050971, 8010042, 3007603826, 3012667060, 3006240053, 9680661, 3023272766, 3010817335, 3010088563 +91 more
- FEI number
- 2024500, 3002807850, 3003135857, 3005783425, 3017520736, 1924066, 3016723884, 3003908598, 3010157426, 3010882708, 3029871637, 3002806988, 3008264065, 1000524541, 1316463, 3002797442, 3009129579, 2021710, 3002924544, 3014766741, 3003862188, 3021947238, 1218058, 3002808440, 3008496839, 3011213495, 1222088, 3032026475, 3009302812, 3021244152, 3044156918, 3004050971, 3007603826, 3012667060, 3006240053, 3023272766, 3010817335, 3010088563, 3029227324, 3003477135 +91 more