Welch Allyn CP150 Electrocardiograph recalled for battery-related fire risk
Baxter Healthcare is recalling Welch Allyn CP150 Electrocardiographs due to reports of battery-related fires. The affected devices used unapproved third-party batteries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Score 3 per FDA Class II classification with documented device fires but no reported hospitalizations or injuries. The hazard poses a credible risk of harm, but injury outcomes have not been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling Welch Allyn CP150 Electrocardiograph devices worldwide, including throughout the United States. The recall affects 41,739 units across multiple product code variants and serial numbers.
Customer reports documented battery-related fires in affected devices. An investigation by Baxter determined that these fires resulted from the use of unapproved, third-party after-market batteries that do not meet Baxter's specifications.
Users of affected CP150 devices should discontinue use of third-party batteries immediately and contact Baxter Healthcare for guidance on approved replacement batteries. Facilities should review their battery sourcing practices to ensure only authorized Baxter batteries are used in these devices.
The recalled product
- Product
- Welch Allyn CP150 Electrocardiograph:
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- fire
- burn-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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