Reported Oct 16, 2024 · Ongoing

Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006,…

Auris Health Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AURIS HEALTH INC · 150 Shoreline Dr · Redwood City, CA · 94065-1400

Is this the product you have?

Monarch Platform (Endoscopy)
REFMON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy)
REF
- MON-000006
- MON-000006-RFB

Lot codes and dates: 3 of 3 products · 175 lot codes
Recalled lot codes, grouped by product number
REF UDI-DI / Serial Numbers
MON-000005-01
+B634MON000005010/110024
13
110014
110016
110040
110038
110027
110035
110022
110034
1806P2
120170
110045
110039
110049
110047
110052
110030
110032
110021
110043
110050
110029
110033
110046
110048
110018
110015
110051
1806P1
110012
14
110041
110036
MON-000005-01R
+B634MON00000501R0/110020
110017
110031
110028
120042
110013. MON-000006/+B634MON0000060/120088
120057
120046
120058
120121
120152
120015
120160
120068
120167
120025
120030
120044
120093
120040
120063
120092
120173
120036
120064
120122
120056
120128
120017
120089
120075
120031
120169
120113
120168
120055
120148
120014
120060
120124
120164
120123
120007
120006
120004
120120
120126
120082
120047
120051
120020
120103
120153
120108
120037
120074
120005
120130
120095
120096
120009
120111
120022
120054
120163
120027
120090
120141
120072
120155
120101
120143
120125
120052
120100
120050
120098
120045
120131
120013
120105
120165
120136
120029
120041
120139
120137
120053
120028
120034
120085
120019
120049
120209
120144
120161
120001
120145
120127
120011
120070
120076
120134
120117
120077
120149
120102
120002
120010
120003
120023
120146
120043
120071
120107
120065
120116
120150
120066
120166
120033
120079
120008
120132
120086
120032
120073
120016
120080
120078
120012
120084
120083
120038
120067
120021
MON-000006-RFB
+B634MON0000060/120081
120026
120091
120106
120104
Amount recalled: 176

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Monarch Platform (Urology)

Where it was sold

Why it was recalled

Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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REF	UDI-DI / Serial Numbers
`MON-000005-01`	`+B634MON000005010/110024` `13` `110014` `110016` `110040` `110038` `110027` `110035` `110022` `110034` `1806P2` `120170` `110045` `110039` `110049` `110047` `110052` `110030` `110032` `110021` `110043` `110050` `110029` `110033` `110046` `110048` `110018` `110015` `110051` `1806P1` `110012` `14` `110041` `110036`
`MON-000005-01R`	`+B634MON00000501R0/110020` `110017` `110031` `110028` `120042` `110013. MON-000006/+B634MON0000060/120088` `120057` `120046` `120058` `120121` `120152` `120015` `120160` `120068` `120167` `120025` `120030` `120044` `120093` `120040` `120063` `120092` `120173` `120036` `120064` `120122` `120056` `120128` `120017` `120089` `120075` `120031` `120169` `120113` `120168` `120055` `120148` `120014` `120060` `120124` `120164` `120123` `120007` `120006` `120004` `120120` `120126` `120082` `120047` `120051` `120020` `120103` `120153` `120108` `120037` `120074` `120005` `120130` `120095` `120096` `120009` `120111` `120022` `120054` `120163` `120027` `120090` `120141` `120072` `120155` `120101` `120143` `120125` `120052` `120100` `120050` `120098` `120045` `120131` `120013` `120105` `120165` `120136` `120029` `120041` `120139` `120137` `120053` `120028` `120034` `120085` `120019` `120049` `120209` `120144` `120161` `120001` `120145` `120127` `120011` `120070` `120076` `120134` `120117` `120077` `120149` `120102` `120002` `120010` `120003` `120023` `120146` `120043` `120071` `120107` `120065` `120116` `120150` `120066` `120166` `120033` `120079` `120008` `120132` `120086` `120032` `120073` `120016` `120080` `120078` `120012` `120084` `120083` `120038` `120067` `120021`
`MON-000006-RFB`	`+B634MON0000060/120081` `120026` `120091` `120106` `120104`

Is this the product you have?

This recall covers 2 products

Where it was sold

Why it was recalled

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