Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of
FDA device recall Z-2323-2024 · posted 2024-07-10 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- 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.
- Action taken
- On 06/03/2024, Baxter Healthcare's Customer Service team contacted the consignee, via telephone call, to discuss the recall action and request the affected unit be returned to Baxter.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- DPS
- Quantity affected
- 1 unit
- Distribution
- Distribution to Illinois.
- Date initiated
- 2024-06-03
- Date posted
- 2024-07-10
- Location
- Deerfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION (K141582) | Welch Allyn | 2014-07-11 |