Reported Dec 25, 2019 · Terminated

Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366…

GE Healthcare, LLC

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: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

125 of 125 products

Products covered by this recall
Model / number	Product as published
`1009-9000-000-009469`	Aespire 7100, Model Numbers: 1.
`1009-9000-000`	2.
`1009-9000-000-013913`	3.
`1009-9000-000-001366`	4.
`1009-9000-000-009857`	5.
`1009-9003-000`	6.
`1009-9000-000-008120`	7.
`1009-9000-000-009600`	8.
`1009-9000-000-014290`	9.
`1009-9000-000-010585`	10.
`1009-9000-000-004993`	11.
`1009-9011-000-004795`	12.
`1009-9000-000-013407`	13.
`1009-9000-000-004604`	14.
`1009-9000-000-017674`	15.
`1009-9000-000-008763`	16.
`1009-9000-000-008306`	17.
`1009-9000-000-003277`	18.
`1009-9000-000-004166`	19.
`1009-9000-000-008560`	20.

Lot codes and dates: Model, Catalogue or Code # Mfg. Lot or Serial #
2,604 of 2,604 codes
1006-9012-000
AMVE00253
1006-9012-000
AMVF00911
1006-9012-000
AMVE00255
1006-9012-000
AMVF00605
1006-9012-000
AMVF00718
1006-9012-000
AMVF00920
1006-9012-000
AMVG00384
1006-9012-000
AMVE00252
1006-9012-000
AMVE00297
1006-9012-000
AMVF00373
1006-9012-000
AMVF00604
1006-9012-000
AMVF00677
1006-9012-000
AMVF00796
1006-9012-000
AMVF00797
1006-9012-000
AMVF01008
1006-9012-000
AMVE00298
1006-9012-000
AMVE00358
1006-9012-000
AMVE00322
1006-9012-000
AMVE00258
1006-9012-000
AMVE00259
1006-9012-000
AMVE00280
1006-9012-000
AMVE00281
1006-9012-000
AMVE00299
1006-9012-000
AMVH00464
1006-9012-000
AMVE00254
1006-9012-000
AMVE00256
1006-9012-000
AMVE00257
1006-9012-000
AMVE00324
1006-9012-000
AMVE00325
1006-9012-000
AMVG00363
1
Amount recalled: 19351 devices

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Why it was recalled

Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters.

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

Want the full recall guide?

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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152 in total.

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