Recall Z-2323-2024 ยท DPS Electrocardiograph
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, diagnose, and monitor patient cardiac function.
| Date | Jul 10, 2024 (initiated Jun 3, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 1 unit |
| Distribution | Distribution to Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION Welch Allyn, Jul 11, 2014 |