FDA recall Z-1725-2025

Baxter Healthcare Corporation · Class I · device

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 for recall

A cybersecurity vulnerability was discovered through internal testing.

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-04-07
Report date
2025-05-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1725-2025