Baxter Healthcare Corporation Recall 94805
Description: 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.
Baxter Healthcare Corporation Recall 94805 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2323-2024 |
| Event ID | 94805 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Distribution to Illinois. |
| Quantity | 1 unit |
| Recall 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. |
| Device Classification | 20240717 |
| Device Code Info | UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024 |
| Center Classification Date | 20240710 |
| Recall Initiation Date | 20240603 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Telephone |
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