FDA Medical Device Recalls (openFDA)
Philips North America LLC: HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
- Recall number
- Z-0603-2019
- Recalling firm
- Philips North America LLC
- Product
- HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
- Status
- Terminated
- Initiated
- 2018-11-23
- Posted
- not on file
- Terminated
- 2020-09-29
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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 recall.response@philips.com. 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.
- Quantity
- 1880 Batteries
- 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
- Lot, serial or model codes
- UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P
- 510(k) numbers
- ["K051134"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28