FDA recall Z-1558-2022

Siemens Medical Solutions USA, Inc · Class III · device

Product

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.

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2022-07-12
Report date
2022-08-24
Termination date
2024-11-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1558-2022