Z-1560-2025Class II

Welch Allyn CP150 Electrocardiograph

Name: Z-1560-2025 Welch Allyn CP150 Electrocardiograph
Creator: Baxter Healthcare Corporation
Published: 2025-03-24
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-03-24 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Welch Allyn CP150 Electrocardiograph on 2025-03-24. FDA classified it as Class II and gives the reason as "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". 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-1560-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-24
Posted: 2025-04-14
Recalling firm: Baxter Healthcare Corporation
Product: Welch Allyn CP150 Electrocardiograph:
Product code: DPS Electrocardiograph
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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
Quantity in commerce: 41,739 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1560-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1558-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-14
Z-1559-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-14
Z-1560-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-14

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)