Z-2323-2024Class II

Welch Allyn CP150 Electrocardiograph with Spirometry Option

Name: Z-2323-2024 Welch Allyn CP150 Electrocardiograph with Spirometry Option
Creator: Baxter Healthcare Corporation
Published: 2024-06-03
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-06-03 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to... on 2024-06-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2323-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-03
Posted: 2024-07-10
Recalling firm: Baxter Healthcare Corporation
Product: 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 code: DPS Electrocardiograph
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1 unit
Distribution: Distribution to Illinois.
Product codes and lots: UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2323-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2323-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-10

Product code DPS

K141582Class IICp150 Electrocardiograph with Spirometry OptionWelch Allyn / cleared 2014-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)