—#213003

Product

Welch Allyn CP150 Electrocardiograph:

FDA product code: DPS — Electrocardiograph
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K141582
Affected lot / code info: 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;

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.

Root cause (FDA determination)

Process design

Action the firm took

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

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide - US Nationwide distribution.

Timeline

Recall initiated: 2025-03-24
Posted by FDA: 2025-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213003. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.