| | Class 2 Device Recall CP150 Electrocardiograph |  |
| Date Initiated by Firm | March 24, 2025 |
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| Date Posted | April 14, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1560-2025 |
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| Recall Event ID |
96478 |
| 510(K)Number | K141582 |
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| Product Classification |
Electrocardiograph - Product Code DPS
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| Product | Welch Allyn CP150 Electrocardiograph: |
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| Code Information |
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;
|
Recalling Firm/
Manufacturer |
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
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| For Additional Information Contact | Center for One Baxter
800-422-9837 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Process design |
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| 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 |
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| Quantity in Commerce | 41,739 units |
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| Distribution | Worldwide - US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = DPS
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