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GE Medical B105M Patient Monitor, REF 6160000-003 - safety alert

Official notice

28 Dec 2022

Last checked

28 Dec 2022

Medium riskFDA
Watch GE Medical↗

An official FDA notice concerns GE Medical B105M Patient Monitor, REF 6160000-003 - safety alert. An official FDA notice concerns B105M Patient Monitor, REF 6160000-003. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-12-28. Models: 6160000-003, 6160000-003-01034677, 6160000-003-01036673, 6160000-003-01045082, 6160000-003-01047272 and 171 more. Recall numbers: Z-0731-2023. Check the official notice for the complete list. Published 2022-12-28.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

3,905

Recall number

Z-0731-2023

Official notice

2022-12-28

Watch this recall in the appOpen source hub ↗

The hazard

An official FDA notice concerns B105M Patient Monitor, REF 6160000-003. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-12-28. Models: 6160000-003, 6160000-003-01034677, 6160000-003-01036673, 6160000-003-01045082, 6160000-003-01047272 and 171 more. Recall numbers: Z-0731-2023. Check the official notice for the complete list.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

6160000-003, 6160000-003-01034677, 6160000-003-01036673, 6160000-003-01045082, 6160000-003-01047272, 6160000-003-01054632, 6160000-003-01054644, 6160000-003-01054806, 6160000-003-01056201, 6160000-003-01058032, 6160000-003-01058330, 6160000-003-01059142, 6160000-003-01060133, 6160000-003-01062599, 6160000-003-01079753, 6160000-003-01086095, 6160000-003-100174, 6160000-003-100318, 6160000-003-100392, 6160000-003-100536, 6160000-003-100708, 6160000-003-100729, 6160000-003-100767, 6160000-003-101032, 6160000-003-101186, 6160000-003-101526, 6160000-003-101926, 6160000-003-102243, 6160000-003-102677, 6160000-003-704369, 6160000-003-704801, 6160000-003-704821, 6160000-003-705415, 6160000-003-708126, 6160000-003-711316, 6160000-003-725905, 6160000-003-732539, 6160000-003-751658, 6160000-003-754973, 6160000-003-759088, 6160000-003-762270, 6160000-003-762969, 6160000-003-773426, 6160000-003-777774, 6160000-003-778824, 6160000-003-779424, 6160000-003-779960, 6160000-003-781926, 6160000-003-783867, 6160000-003-784409, 6160000-003-786099, 6160000-003-787699, 6160000-003-789100, 6160000-003-790654, 6160000-003-791238, 6160000-003-791758, 6160000-003-792034, 6160000-003-794507, 6160000-003-794812, 6160000-003-795091, 6160000-003-795092, 6160000-003-795094, 6160000-003-795118, 6160000-003-799103, 6160000-003-799104, 6160000-003-799902, 6160000-003-800999, 6160000-003-801018, 6160000-003-801027, 6160000-003-802038, 6160000-003-802087, 6160000-003-803893, 6160000-003-804280, 6160000-003-804607, 6160000-003-804618, 6160000-003-805361, 6160000-003-806940, 6160000-003-806995, 6160000-003-808220, 6160000-003-810740, 6160000-003-816782, 6160000-003-816915, 6160000-003-824388, 6160000-003-826780, 6160000-003-828525, 6160000-003-828543, 6160000-003-828913, 6160000-003-833494, 6160000-003-833611, 6160000-003-835230, 6160000-003-835231, 6160000-003-836150, 6160000-003-847700, 6160000-003-848258, 6160000-003-848483, 6160000-003-849018, 6160000-003-849661, 6160000-003-853190, 6160000-003-861504, 6160000-003-861505, 6160000-003-864186, 6160000-003-870691, 6160000-003-880803, 6160000-003-884726, 6160000-003-885352, 6160000-003-886633, 6160000-003-888222, 6160000-003-888524, 6160000-003-888656, 6160000-003-893447, 6160000-003-896220, 6160000-003-896752, 6160000-003-898312, 6160000-003-901656, 6160000-003-901668, 6160000-003-904149, 6160000-003-905171, 6160000-003-906538, 6160000-003-908054, 6160000-003-910231, 6160000-003-913985, 6160000-003-914443, 6160000-003-914507, 6160000-003-916225, 6160000-003-916226, 6160000-003-916983, 6160000-003-917353, 6160000-003-918182, 6160000-003-920906, 6160000-003-928705, 6160000-003-933067, 6160000-003-933125, 6160000-003-934563, 6160000-003-934689, 6160000-003-934886, 6160000-003-937538, 6160000-003-937742, 6160000-003-938923, 6160000-003-939344, 6160000-003-939345, 6160000-003-942012, 6160000-003-942654, 6160000-003-947313, 6160000-003-947375, 6160000-003-949796, 6160000-003-951507, 6160000-003-953832, 6160000-003-954834, 6160000-003-955152, 6160000-003-960005, 6160000-003-961398, 6160000-003-966613, 6160000-003-966639, 6160000-003-967018, 6160000-003-969067, 6160000-003-971402, 6160000-003-971519, 6160000-003-971881, 6160000-003-972727, 6160000-003-975437, 6160000-003-976613, 6160000-003-978919, 6160000-003-979378, 6160000-003-980633, 6160000-003-980642, 6160000-003-982420, 6160000-003-983421, 6160000-003-988264, 6160000-003-994029, 6160000-003-994031, 6160000-003-994534, 6160000-003-995139, 6160000-003-995681, 6160000-003-996254, 6160000-003-998376, 6160000-003-999463

Event Ids

91176

Model Numbers

6160000-003, 6160000-003-01034677, 6160000-003-01036673, 6160000-003-01045082, 6160000-003-01047272, 6160000-003-01054632, 6160000-003-01054644, 6160000-003-01054806, 6160000-003-01056201, 6160000-003-01058032, 6160000-003-01058330, 6160000-003-01059142, 6160000-003-01060133, 6160000-003-01062599, 6160000-003-01079753, 6160000-003-01086095, 6160000-003-100174, 6160000-003-100318, 6160000-003-100392, 6160000-003-100536, 6160000-003-100708, 6160000-003-100729, 6160000-003-100767, 6160000-003-101032, 6160000-003-101186, 6160000-003-101526, 6160000-003-101926, 6160000-003-102243, 6160000-003-102677, 6160000-003-704369, 6160000-003-704801, 6160000-003-704821, 6160000-003-705415, 6160000-003-708126, 6160000-003-711316, 6160000-003-725905, 6160000-003-732539, 6160000-003-751658, 6160000-003-754973, 6160000-003-759088, 6160000-003-762270, 6160000-003-762969, 6160000-003-773426, 6160000-003-777774, 6160000-003-778824, 6160000-003-779424, 6160000-003-779960, 6160000-003-781926, 6160000-003-783867, 6160000-003-784409, 6160000-003-786099, 6160000-003-787699, 6160000-003-789100, 6160000-003-790654, 6160000-003-791238, 6160000-003-791758, 6160000-003-792034, 6160000-003-794507, 6160000-003-794812, 6160000-003-795091, 6160000-003-795092, 6160000-003-795094, 6160000-003-795118, 6160000-003-799103, 6160000-003-799104, 6160000-003-799902, 6160000-003-800999, 6160000-003-801018, 6160000-003-801027, 6160000-003-802038, 6160000-003-802087, 6160000-003-803893, 6160000-003-804280, 6160000-003-804607, 6160000-003-804618, 6160000-003-805361, 6160000-003-806940, 6160000-003-806995, 6160000-003-808220, 6160000-003-810740, 6160000-003-816782, 6160000-003-816915, 6160000-003-824388, 6160000-003-826780, 6160000-003-828525, 6160000-003-828543, 6160000-003-828913, 6160000-003-833494, 6160000-003-833611, 6160000-003-835230, 6160000-003-835231, 6160000-003-836150, 6160000-003-847700, 6160000-003-848258, 6160000-003-848483, 6160000-003-849018, 6160000-003-849661, 6160000-003-853190, 6160000-003-861504, 6160000-003-861505, 6160000-003-864186, 6160000-003-870691, 6160000-003-880803, 6160000-003-884726, 6160000-003-885352, 6160000-003-886633, 6160000-003-888222, 6160000-003-888524, 6160000-003-888656, 6160000-003-893447, 6160000-003-896220, 6160000-003-896752, 6160000-003-898312, 6160000-003-901656, 6160000-003-901668, 6160000-003-904149, 6160000-003-905171, 6160000-003-906538, 6160000-003-908054, 6160000-003-910231, 6160000-003-913985, 6160000-003-914443, 6160000-003-914507, 6160000-003-916225, 6160000-003-916226, 6160000-003-916983, 6160000-003-917353, 6160000-003-918182, 6160000-003-920906, 6160000-003-928705, 6160000-003-933067, 6160000-003-933125, 6160000-003-934563, 6160000-003-934689, 6160000-003-934886, 6160000-003-937538, 6160000-003-937742, 6160000-003-938923, 6160000-003-939344, 6160000-003-939345, 6160000-003-942012, 6160000-003-942654, 6160000-003-947313, 6160000-003-947375, 6160000-003-949796, 6160000-003-951507, 6160000-003-953832, 6160000-003-954834, 6160000-003-955152, 6160000-003-960005, 6160000-003-961398, 6160000-003-966613, 6160000-003-966639, 6160000-003-967018, 6160000-003-969067, 6160000-003-971402, 6160000-003-971519, 6160000-003-971881, 6160000-003-972727, 6160000-003-975437, 6160000-003-976613, 6160000-003-978919, 6160000-003-979378, 6160000-003-980633, 6160000-003-980642, 6160000-003-982420, 6160000-003-983421, 6160000-003-988264, 6160000-003-994029, 6160000-003-994031, 6160000-003-994534, 6160000-003-995139, 6160000-003-995681, 6160000-003-996254, 6160000-003-998376, 6160000-003-999463

Recall Numbers

Z-0731-2023

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Affected products

Product 1

B105M Patient Monitor, REF 6160000-003

Units affected

3,905

Risk / hazard

An official FDA notice concerns B105M Patient Monitor, REF 6160000-003. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-12-28. Models: 6160000-003, 6160000-003-01034677, 6160000-003-01036673, 6160000-003-01045082, 6160000-003-01047272 and 171 more. Recall numbers: Z-0731-2023. Check the official notice for the complete list.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States · WI · Waukesha

Affected area 1

US · United States · WI · Waukesha

Affected area 2

US · United States

Company & contacts

Brand

GE Medical

Manufacturer

Not provided

Phone

Not provided

Brand: GE Medical. Contact: GE Medical Systems, LLC.

Source & status

Source

FDA

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-0731-2023

Event id

91176

Units affected

3,905

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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