Welch Allyn CP150 Electrocardiograph with Spirometry… recallZ-2323-2024 · Baxter Healthcare Corporation · initiated Jun 3, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-2323-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 3, 2024
- Posted by the FDA
- Jul 10, 2024
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 1 unit
- Product code
- DPS
- FDA submissions
- K141582
- Distribution
- Distribution to Illinois.
Product 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.
Code information (models, lots, serial numbers)
UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Welch Allyn, Inc. 901049Welch Allyn, Inc. · ELECTROCARDIOGRAPH2 recalls0 reports
Other devices under the same FDA submission
3 devices cleared under K141582 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Welch Allyn, Inc. 901049Welch Allyn, Inc. · ELECTROCARDIOGRAPH1 recall0 reports
- Welch Allyn, Inc. 901049Welch Allyn, Inc. · ELECTROCARDIOGRAPH1 recall0 reports
- Welch Allyn, Inc. 901049Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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