Baxter Healthcare Corporation recalls Welch Allyn CP150 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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Welch Allyn CP150 Electrocardiograph:
Lot / code information
- Serial #
- . Product Code: CP150-2ES2
- UDI
- 00732094192131; Product Code: CP150-2FR2
- UDI
- 00732094192124; Product Code: CP150-2FR5
- UDI
- 00732094192117; Product Code: CP150-2NL2
- UDI
- 00732094192100; Product Code: CP150-2PT2
- UDI
- 00732094192087; Product Code: CP150-2SV2
- UDI
- 00732094192070; Product Code: CP150-3ENB
- UDI
- 00732094179705; Product Code: CP150-3ESB
- UDI
- 00732094179682; Product Code: CP150-4DE2
- UDI
- 00732094192063; Product Code: CP150-4EN2
- UDI
- 00732094179675; Product Code: CP150-4EN4
- UDI
- 00732094179668; Product Code: CP150-4PT2
- UDI
- 00732094192025; Product Code: CP150A-1EN2
- UDI
- 00732094185157; Product Code: CP150A-1EN4
- UDI
- 00732094185140; Product Code: CP150A-1EN66
- UDI
- 00732094179644; Product Code: CP150A-1ENB
- UDI
- 00732094177633; Product Code: CP150A-1ENBR
- UDI
- 00732094322415; Product Code: CP150A-1ESB
- UDI
- 00732094192230; Product Code: CP150A-1FRB
- UDI
- 00732094179637; Product Code: CP150A-2DE2
- UDI
- 00732094192018; Product Code: CP150A-2DE5
- UDI
- 00732094192001; Product Code: CP150A-2EN2
- UDI
- 00732094177626; Product Code: CP150A-2EN3
- UDI
- 00732094179620; Product Code: CP150A-2EN4
- UDI
- 00732094177619; Product Code: CP150A-2EN7
- UDI
- 00732094191998; Product Code: CP150A-2ES2
- UDI
- 00732094191981; Product Code: CP150A-2FR2
- UDI
- 00732094191974; Product Code: CP150A-2FR5
- UDI
- 00732094191967; Product Code: CP150A-2NL2
- UDI
- 00732094191950; Product Code: CP150A-2NO2
- UDI
- 00732094191943; Product Code: CP150A-2SV2
- UDI
- 00732094191929; Product Code: CP150A-3BPZ
- UDI
- 00732094212938; Product Code: CP150A-3EN2
- UDI
- 00732094179613; Product Code: CP150A-3EN3
- UDI
- 00732094179606; Product Code: CP150A-3EN4
- UDI
- 00732094184815; Product Code: CP150A-3ENB
- UDI
- 00732094179590; Product Code: CP150A-3ES2
- UDI
- 00732094179583; Product Code: CP150A-3ESB
- UDI
- 00732094177602; Product Code: CP150A-3ZHC-CN
- UDI
- 00732094213515; Product Code: CP150A-4BPZ
- UDI
- 00732094212952; Product Code: CP150A-4DE2
- UDI
- 00732094191912; Product Code: CP150A-4EN2
- UDI
- 00732094177596; Product Code: CP150A-4EN4
- UDI
- 00732094177589; Product Code: CP150A-4ES2
- UDI
- 00732094177572; Product Code: CP150A-4FR5
- UDI
- 00732094189186; Product Code: CP150A-4PT2
- UDI
- 00732094189179; Product Code: CP150A-4ZHC-CN
- UDI
- 00732094213539; Product Code: CP150AD-1ENB
- UDI
- 00732094237580; Product Code: CP150AD-2DE2
- UDI
- 00732094237573; Product Code: CP150AD-2ES2
- UDI
- 00732094237559; Product Code: CP150ADS-1EN66
- UDI
- 00732094242171; Product Code: CP150AS-1EN66
- UDI
- 00732094333244; Product Code: CP150AS-1ENB
- UDI
- 00732094185133; Product Code: CP150AW-1EN66
- UDI
- 00732094237511; Product Code: CP150-2EN7
- UDI
- 00732094192148; Product Code: CP150-1EN2
- UDI
- 00732094185171; Product Code: CP150-1EN66
- UDI
- 00732094179750; Product Code: CP150-1ENB
- UDI
- 00732094177640; Product Code: CP150-1FRB
- UDI
- 00732094192254; Product Code: CP150-2DE2
- UDI
- 00732094192162; Product Code: CP150-2EN2
- UDI
- 00732094179743; Product Code: CP150-2EN4
- UDI
- 00732094179729; Product Code: CP150AW-1ENB
- UDI
- 00732094237504; Product Code: CP150AW-2DE2
- UDI
- 00732094237498; Product Code: CP150AW-2EN4
- UDI
- 00732094237481; Product Code: CP150AW-2ES2
- UDI
- 00732094237474; Product Code: CP150AW-2NL2
- UDI
- 00732094237467; Product Code: CP150AW-3ENB
- UDI
- 00732094242003; Product Code: CP150AWD-1EN66
- UDI
- 00732094237436; Product Code: CP150AWD-1ENB
- UDI
- 00732094237429; Product Code: CP150AWD-2DE2
- UDI
- 00732094237412; Product Code: CP150AWD-2EN4
- UDI
- 00732094237405; Product Code: CP150AWD-2ES2
- UDI
- 00732094237399; Product Code: CP150AWD-2NL2
- UDI
- 00732094237382; Product Code: CP150AWD-4EN4
- UDI
- 00732094237368; Product Code: CP150AWDS-1ENB
- UDI
- 00732094241686; Product Code: CP150AWDS-3ENB
- UDI
- 00732094241662; Product Code: CP150AWS-1ENB
- UDI
- 00732094243437; Product Code: CP150S-1ENB
- UDI
- 00732094222302; Product Code: CP150W-1ENB
- UDI
- 00732094232837
Show 71 more code fieldsShow fewer
What the firm 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
DistributionShow detailsHide
Worldwide - US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1560-2025
- FDA 510(k) clearance · K141582The device's official FDA premarket clearance record
- FDA device classification · DPSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.2340The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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