Product Safety Recalls

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AURIS HEALTH INC Recall 93320

Description: Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w

AURIS HEALTH INC Recall 93320 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0450-2024
Event ID93320
Event DescriptionMonarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Product TypeDevices
DistributionUS Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WI & WV.
Quantity110 units In total
Recall ReasonTheir is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Device Classification20231213
Device Code InfoSoftware version 2.2.4
Center Classification Date20231201
Recall Initiation Date20231018
Recalling FirmAURIS HEALTH INC
Initial Notification E-Mail
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