FDA-Device2026-09-23Class IIPROCESSING DEFECT
Boston Scientific StoneSmart Connect Console power adapters recalled for electrical grounding failure risk
What this means
Certain power adapters used with the StoneSmart Connect Console may have higher-than-expected electrical resistance in the grounding path. These adapters may fail electrical safety testing during installation, which could affect device safety.
- Check if your console power adapter matches one of the affected model numbers (M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, or M0067930000).
- Contact Boston Scientific for a replacement adapter or further instructions.
- Do not use the console until you have confirmed your power adapter is safe or received a replacement.
The agency's original wording
Hazard
A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution including in the states of AZ, FL, CA, OR, IL, NC, NE, UT, CO, OH, AR, NM, AL, WI, TN, IN, GA, OH, WI, KY, CT, KS, SC, IL, NE, MO, MS, DE, TX, NY, WV, MA, MT, WA, WY, NV, HI, ID, MO, ME, WV, NE, OK, MN, LA, WV, NV, PA, NH, NJ, MI, MO, AK, VA, MS, WY, ME and the countries of Australia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkiye, Canada, Hong Kong, Singapore, Taiwan, Argentina, Chile, Japan.
Affected count
982 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3188-2026More Boston Scientific recalls
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