HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Reported: May 22, 2024 Initiated: April 8, 2024 #Z-1820-2024
Product Description
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Reason for Recall
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
Details
- Recalling Firm
- HeartSine Technologies Ltd
- Units Affected
- 183,248
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.
- Location
- Belfast, N/A
Frequently Asked Questions
What product was recalled? ▼
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P. Recalled by HeartSine Technologies Ltd. Units affected: 183,248.
Why was this product recalled? ▼
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1820-2024.
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