ClearanceBrief
Recall Z-1558-2022 ยท DQK Computer, Diagnostic, Programmable

Siemens Medical Solutions USA, Inc

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 sup

DateJul 12, 2022
StatusTerminated
ReasonThe 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
Root causeDevice Design
ActionSiemens 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. F
Quantity399 units U.S.
DistributionUS 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 Ec
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K150493Sensis
Siemens Medi Cal Solutions, Inc., Jun 30, 2015