FDA Device recall Z-1725-2025
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002
- FDA Device
- Class I
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class I recall of Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002 by Baxter Healthcare, citing A cybersecurity vulnerability was discovered through internal testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1725-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-04-07 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
Reason
A cybersecurity vulnerability was discovered through internal testing.
Identifiers
| code_info | ALL SERIAL NUMBERS: 1) BT-20-0002, UDI/DI 00815410020537 or 00887761978089; 2) BT-20-0002A, UDI/DI 00815410020537 of…ALL SERIAL NUMBERS: 1) BT-20-0002, UDI/DI 00815410020537 or 00887761978089; 2) BT-20-0002A, UDI/DI 00815410020537 of 00887761978089; 3) BT-20-0002AP, UDI/DI 00815410020537 or 00887761978089; 4) BT200007, UDI/DI 00815410020278 or 00887761978089; 5) BT-20-0007, UDI/DI 00815410020278 or 00887761978089; 6) BT200011, UDI/DI 00815410020537 or 00887761978089; 7) BT-20-0011, UDI/DI 00815410020537 or 00887761978089; 8) RMS010118CP, UDI/DI 00815410020537 or 00887761978089. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1725-2025%22
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