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Terminated

AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology.

FDA Recall Z-1558-2022 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeDQK
Date Initiated2022-07-12
Date Terminated2024-11-07
Product Quantity399 units U.S.

Reason for Recall

The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting position deviates from the default position, the following are possible: Patient touching the Signal Input Box may result in a touch leakage current to the patient; Spillage of liquid entering the Signal Input Box

Firm Action

Siemens Healthineers issued Urgent Medical Device Correction letter dated 7/12/22 to US consignees. The letter states the reason for recall, health risk and action to take: Please follow the instructions in the attached addendum which are a supplement to the Operator Manual chapter "Positioning the signal input box". Siemens has updated the affected documentation and is distributing an Addendum to the Operator Manual to all affected customers via Update Instruction AX033/21/S. Please file this Customer Safety Advisory Notice and Addendum to the Operator Manual with all system documentation. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution Foreign: Albania Algeria Angola Argentina Armenia Aruba Australia Austria Azerbaijan Bahrain Bangladesh Belgium Bolivia Bosnia and Herzegovina Brunei Darussalam Bulgaria Cambodia Cameroon Canada Chile China Colombia Costa Rica Croatia Cuba Cyprus Czech Republic Denmark Ecuador Egypt El Salvador Estonia Ethiopia Finland France Georgia Germany Ghana Greece Guatemala Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kosovo Kuwait Latvia Lebanon Libya Luxembourg Macao Malaysia Maldives Mali Mauritius Mexico Moldova Montenegro Morocco Mozambique Myanmar Namibia Netherlands New Caledonia New Zealand Nigeria North Korea Norway Oman Pakistan Palestine, State of Panama Paraguay Peru Philippines Poland Portugal Qatar Romania Rwanda Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sudan Suriname Sweden Switzerland Syria Taiwan Tajikistan Tanzania Thailand Trinidad and Tobago Tunisia Turkey Turkmenistan Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Venezuela, Bolivarian Republic of Vietnam Yemen

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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