HeartSine Defibrillators Recalled for Missing Maintenance Supplement
HeartSine Technologies is recalling 31,834 public access defibrillators distributed without the required Maintenance Supplement, which describes an extra check every 3 months.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a missing documentation supplement rather than a functional defect or contamination.
Plain-English summary
HeartSine Technologies Ltd is recalling 31,834 units of HeartSine samaritan PAD public access defibrillators, including SAM 350P, SAM 360P, and SAM 450P models. The affected devices were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
The recall covers devices distributed nationwide in the U.S., including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Specific serial numbers and UDI-DI codes for the affected units are listed in the official recall notice.
Consumers and facility managers should check their devices against the list of affected serial numbers and UDI-DI codes provided by the FDA. If a device is affected, they should contact HeartSine Technologies for instructions on obtaining the required Maintenance Supplement.
The recalled product
- Product
- HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with…
- Manufacturer
- HeartSine Technologies Ltd
- Category
- Medical Device — Defibrillator
- Hazard
- Affected units
- 31,834
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product - 350P US Device
Distribution
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