Welch Allyn CP150 Electrocardiograph recalled for missing electromagnetic interference absorber
Baxter Healthcare is recalling the Welch Allyn CP150 Electrocardiograph because a critical manufacturing step—installation of an electromagnetic interference absorber—was omitted. This could cause device malfunction or interference with nearby medical equipment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential device malfunction or EMI interference—rather than confirmed adverse events. Per the rubric, theoretical hazards without reported harm score at most 3.
Plain-English summary
Baxter Healthcare Corporation is recalling the Welch Allyn CP150 Electrocardiograph with Spirometry Option (Product Code CP150A-1ENB, Serial Number 100013892024). This device is used by clinicians to evaluate, diagnose, and monitor patient cardiac function.
During manufacturing, a critical step was omitted: installation of an electromagnetic interference (EMI) absorber. This component prevents EMI leakage that could otherwise cause the device to malfunction or interfere with other nearby medical devices.
The affected device was distributed to Illinois.
The recalled product
- 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.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024
Distribution
Distributed in 1 state:
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