Recall archive / FDA device enforcement
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one... — FDA record Z-2323-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 3, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2323-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution to Illinois.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 17, 2024
- Recall initiation date
- Jun 3, 2024
- Center classification date
- Jul 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.