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Welch Allyn CP150 Electrocardiograph recallZ-1560-2025 · Baxter Healthcare Corporation · initiated Mar 24, 2025

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

FDA root cause category: Process design

What the company is doing

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 3/24/25 was sent to customers. Actions to be Taken by Customers 1. DO NOT USE UNAPPROVED BATTERIES. Baxter asks customers to only use the approved Baxter / Welch Allyn BATT99 battery, consistent with product labeling due to their safety and performance testing. 2. INSPECT ALL DEVICES. If you have a device identified in the affected product table above, check the device for the correct battery type. See Figure 1 below for examples of labels from approved batteries labelled with the BATT99 product code, Welch Allyn , and the Skaneateles Falls manufacturing facility address. 3. STOP USING THE DEVICE if an unapproved battery is found. 4. IMMEDIATELY REPLACE THE UNAPPROVED BATTERY with an approved battery. Please contact Baxter to order the approved Baxter / Welch Allyn BATT99 batteries. Batteries can be ordered at the following link: https://parts.hillrom.com/hillromUS/en 5. Please forward a copy of this communication to the Medical Director/Office Manager, Director of Biomedical Engineering, Patient Safety Officer, Risk Manager, Surgical Director and any other departments within your institution who use the affected product. 6. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 7. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 8. If you are a dealer/wholesaler, distributor/reseller or Original Equipment Manufac

Recall details

Recall number
Z-1560-2025
Status
Open, Classified
Initiated by the company
Mar 24, 2025
Posted by the FDA
Apr 14, 2025
Recalling firm
Baxter Healthcare Corporation
Quantity
41,739 units
Product code
DPS
FDA submissions
K141582
Distribution
Worldwide - US Nationwide distribution.

Product description

Welch Allyn CP150 Electrocardiograph:

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

All Serial Numbers. Product Code: CP150-2ES2, UDI-DI: 00732094192131; Product Code: CP150-2FR2, UDI-DI: 00732094192124; Product Code: CP150-2FR5, UDI-DI: 00732094192117; Product Code: CP150-2NL2, UDI-DI: 00732094192100; Product Code: CP150-2PT2, UDI-DI: 00732094192087; Product Code: CP150-2SV2, UDI-DI: 00732094192070; Product Code: CP150-3ENB, UDI-DI: 00732094179705; Product Code: CP150-3ESB, UDI-DI: 00732094179682; Product Code: CP150-4DE2, UDI-DI: 00732094192063; Product Code: CP150-4EN2, UDI-DI: 00732094179675; Product Code: CP150-4EN4, UDI-DI: 00732094179668; Product Code: CP150-4PT2, UDI-DI: 00732094192025; Product Code: CP150A-1EN2, UDI-DI: 00732094185157; Product Code: CP150A-1EN4, UDI-DI: 00732094185140; Product Code: CP150A-1EN66, UDI-DI: 00732094179644; Product Code: CP150A-1ENB, UDI-DI: 00732094177633; Product Code: CP150A-1ENBR, UDI-DI: 00732094322415; Product Code: CP150A-1ESB, UDI-DI: 00732094192230; Product Code: CP150A-1FRB, UDI-DI: 00732094179637; Product Code: CP150A-2DE2, UDI-DI: 00732094192018; Product Code: CP150A-2DE5, UDI-DI: 00732094192001; Product Code: CP150A-2EN2, UDI-DI: 00732094177626; Product Code: CP150A-2EN3, UDI-DI: 00732094179620; Product Code: CP150A-2EN4, UDI-DI: 00732094177619; Product Code: CP150A-2EN7, UDI-DI: 00732094191998; Product Code: CP150A-2ES2, UDI-DI: 00732094191981; Product Code: CP150A-2FR2, UDI-DI: 00732094191974; Product Code: CP150A-2FR5, UDI-DI: 00732094191967; Product Code: CP150A-2NL2, UDI-DI: 00732094191950; Product Code: CP150A-2NO2, UDI-DI: 00732094191943; Product Code: CP150A-2SV2, UDI-DI: 00732094191929; Product Code: CP150A-3BPZ, UDI-DI: 00732094212938; Product Code: CP150A-3EN2, UDI-DI: 00732094179613; Product Code: CP150A-3EN3, UDI-DI: 00732094179606; Product Code: CP150A-3EN4, UDI-DI: 00732094184815; Product Code: CP150A-3ENB, UDI-DI: 00732094179590; Product Code: CP150A-3ES2, UDI-DI: 00732094179583; Product Code: CP150A-3ESB, UDI-DI: 00732094177602; Product Code: CP150A-3ZHC-CN, UDI-DI: 00732094213515; Product Code: CP150A-4BPZ, UDI-DI: 00732094212952; Product Code: CP150A-4DE2, UDI-DI: 00732094191912; Product Code: CP150A-4EN2, UDI-DI: 00732094177596; Product Code: CP150A-4EN4, UDI-DI: 00732094177589; Product Code: CP150A-4ES2, UDI-DI: 00732094177572; Product Code: CP150A-4FR5, UDI-DI: 00732094189186; Product Code: CP150A-4PT2, UDI-DI: 00732094189179; Product Code: CP150A-4ZHC-CN, UDI-DI: 00732094213539; Product Code: CP150AD-1ENB, UDI-DI: 00732094237580; Product Code: CP150AD-2DE2, UDI-DI: 00732094237573; Product Code: CP150AD-2ES2, UDI-DI: 00732094237559; Product Code: CP150ADS-1EN66, UDI-DI: 00732094242171; Product Code: CP150AS-1EN66, UDI-DI: 00732094333244; Product Code: CP150AS-1ENB, UDI-DI: 00732094185133; Product Code: CP150AW-1EN66, UDI-DI: 00732094237511; Product Code: CP150-2EN7, UDI-DI: 00732094192148; Product Code: CP150-1EN2, UDI-DI: 00732094185171; Product Code: CP150-1EN66, UDI-DI: 00732094179750; Product Code: CP150-1ENB, UDI-DI: 00732094177640; Product Code: CP150-1FRB, UDI-DI: 00732094192254; Product Code: CP150-2DE2, UDI-DI: 00732094192162; Product Code: CP150-2EN2, UDI-DI: 00732094179743; Product Code: CP150-2EN4, UDI-DI: 00732094179729; Product Code: CP150AW-1ENB, UDI-DI: 00732094237504; Product Code: CP150AW-2DE2, UDI-DI: 00732094237498; Product Code: CP150AW-2EN4, UDI-DI: 00732094237481; Product Code: CP150AW-2ES2, UDI-DI: 00732094237474; Product Code: CP150AW-2NL2, UDI-DI: 00732094237467; Product Code: CP150AW-3ENB, UDI-DI: 00732094242003; Product Code: CP150AWD-1EN66, UDI-DI: 00732094237436; Product Code: CP150AWD-1ENB, UDI-DI: 00732094237429; Product Code: CP150AWD-2DE2, UDI-DI: 00732094237412; Product Code: CP150AWD-2EN4, UDI-DI: 00732094237405; Product Code: CP150AWD-2ES2, UDI-DI: 00732094237399; Product Code: CP150AWD-2NL2, UDI-DI: 00732094237382; Product Code: CP150AWD-4EN4, UDI-DI: 00732094237368; Product Code: CP150AWDS-1ENB, UDI-DI: 00732094241686; Product Code: CP150AWDS-3ENB, UDI-DI: 00732094241662; Product Code: CP150AWS-1ENB, UDI-DI: 00732094243437; Product Code: CP150S-1ENB, UDI-DI: 00732094222302; Product Code: CP150W-1ENB, UDI-DI: 00732094232837;

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96478).

Sources and updates

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