Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0087-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
PROPONENT SR SL (Model L200)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0085-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE DR EL MRI (Model L331)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0084-2026October 22, 2025Saint Paul, MN
Spacelabs Healthcare, Inc.
Class IIOngoing
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male ...
Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety b...
Z-0169-2026October 22, 2025Snoqualmie, WA
Boston Scientific Corporation
Class IOngoing
ACCOLADE DR SL (Model L301)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0080-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0097-2026October 22, 2025Saint Paul, MN
Spacelabs Healthcare, Inc.
Class IIOngoing
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male ...
Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety b...
Z-0168-2026October 22, 2025Snoqualmie, WA
Boston Scientific Corporation
Class IOngoing
Model Number S701 ALTRUA 2 SR SL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0098-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE DR EL (Model L321)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0083-2026October 22, 2025Saint Paul, MN
Spacelabs Healthcare, Inc.
Class IIOngoing
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male d...
Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety b...
Z-0167-2026October 22, 2025Snoqualmie, WA
Boston Scientific Corporation
Class IOngoing
Model Number L111, ESSENTIO DR SL MRI Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0095-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number U125, VALITUDE CRT-P EL
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Reason: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Z-0145-2026October 22, 2025Pymble
Boston Scientific Corporation
Class IOngoing
Model Number L231, PROPONENT DR EL MRI Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0091-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE SR SL MRI (Model L310)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0081-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L221 PROPONENT DR EL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0090-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE DR SL MRI (Model L311)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0082-2026October 22, 2025Saint Paul, MN
GE Medical Systems, LLC
Class IIOngoing
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Reason: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica...
Z-0155-2026October 22, 2025Waukesha, WI
Boston Scientific Corporation
Class IOngoing
Model Number U225 VISIONIST CRT-P EL
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0103-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number S702, ALTRUA 2 DR SL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0099-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
PROPONENT DR SL (Model L201)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0086-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L110, ESSENTIO SR SL MRI Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0094-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L121 ESSENTIO DR EL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0096-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L210 PROPONENT SR SL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0088-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number S722, ALTRUA 2 DR EL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...