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Boston Scientific Corporation: Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable,

Medical DevicesSource: FDA (device) · Date: 2026-09-23

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Boston Scientific Corporation
Product
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
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-07-22
Code info
All Serial Numbers: REF: M0067933000 (UDI 00191506002510, UDI (00191506021771); REF: M006793300H0 (UDI 00191506002558); REF: M006793300R0 (UDI 00191506002534), UDI (00191506021788); REF: M006793300D0 (UDI 00191506002527); REF: M006793300Z0 (UDI 00191506002541); UPN M0067933100 (UDI 00191506022549)
Product quantity
982 units
Voluntary mandated
Voluntary: Firm initiated
City
Marlborough
State
MA
Country
United States
Event id
99630
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