Recall record at a glance
| Official record | Z-1189-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Physio-Control, Inc. |
| Report date | Mar 17, 2021 |
| Recall initiation date | Jan 14, 2021 |
| Quantity | 89,763 units |
| Location | Redmond, WA, United States |
Official product description
PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.
Why the product was recalled
Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
Distribution information
Worldwide Distribution to U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI , SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV and WY O.U.S. countries of: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Qatar, Saint Barth¿lemy, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
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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