HeartStart recallZ-0603-2019 · Philips North America LLC · initiated Nov 23, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 11/23/2018 Urgent Medical Device Recall notices were mailed via USPS certified mail to customers. Customers were instructed to do the following. Inspect the batteries installed in your monitor/defibrillator to determine if they are affected by this recall. If any affected batteries are found, remove them from service immediately, along with any other affected batteries in your inventory. Further, customers were asked to complete and fax the Customer Reply Form to: +1.877.499.7223 or email to [email protected]. Your monitor/defibrillator can only be returned to service once a charged battery, unaffected by this recall, is installed. Firm will replace affected Rechargeable Lithium-Ion Batteries at no charge to the customer. Firm will contact you when replacement batteries are available. Customers with additional questions are encouraged to call 1-800-722-9377. Distributors were advised to send a copy of the Urgent Medical Device Recall notice and Customer Reply form to any customer to whom they have distributed affected batteries.
Recall details
- Recall number
- Z-0603-2019
- Status
- Terminated
- Initiated by the company
- Nov 23, 2018
- Recalling firm
- Philips North America LLC
- Quantity
- 1880 Batteries
- Product code
- MKJ
- FDA submissions
- K051134
- Distribution
- U.S.: AZ, WA, PA, UT, NY, CO, MD, AR, TX, MO, MI, FL, VA, MA, GA, TN, NV, OH, CA, NH, KY, KS, OR, WI, NC, IL, LA, NJ, WV, AL, WY, MS Foreign (OUS): United Kingdom, Korea Rep, Singapore, Australia, Taiwan, Sri Lanka, Brazil, France, Switzerland, Germany, Austria, Spain, Italy, Trinidad and Tobago, Estonia, Belgium, Portugal, Korea, Republic of, Argentina, India, Puerto Rico, Qatar, Netherlands, Mexico, South Africa, Ireland, Saudi Arabia, New Zealand, Bolivia, Costa Rica, Chile, Canada, Russian Federation, Slovenia
Product description
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
Code information (models, lots, serial numbers)
UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HeartStart MRx Lithium Ion Battery ModulePhilips Medical Systems Hsg · Automated external defibrillators (non-wearable)1 recall12 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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