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Recall Observatory FDA recall evidence

Device 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.

Z-2323-2024

June 03, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 94805
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2323-2024

Official wording

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.

Code information: UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024

Distribution pattern: Distribution to Illinois.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.