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FDA (Device enforcement)Recalled 2024-06-03class ii

Baxter Healthcare Corporation: Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagn

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.

Details from the source

Reason for recall: 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. Distribution: Distribution to Illinois. Quantity: 1 unit Lot/code info: UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024

UPC codes

00732094177640, 100013892024

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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