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U.S. Department of Health and Human Services

Class 2 Device Recall Welch Allyn CP150 Electrocardiograph with Spirometry Option

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 Class 2 Device Recall Welch Allyn CP150 Electrocardiograph with Spirometry Optionsee related information
Date Initiated by FirmJune 03, 2024
Date PostedJuly 10, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2323-2024
Recall Event ID 94805
510(K)NumberK141582 
Product Classification Electrocardiograph - Product Code DPS
ProductWelch 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 UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionOn 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 Commerce1 unit
DistributionDistribution to Illinois.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DPS
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