FDAFDA · Food and drugs·Recall number Z-2323-2024
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
Published July 17, 2024 · Recall initiated: June 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerable to EMI resulting in device malfunction or unavailability.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Distribution to Illinois.
- Lot
- UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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