Recall record at a glance
| Official record | Z-0603-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips North America LLC |
| Report date | Dec 19, 2018 |
| Recall initiation date | Nov 23, 2018 |
| Quantity | 1880 Batteries |
| Location | Bothell, WA, United States |
Official product description
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
Why the product 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.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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