Reported Dec 25, 2019 · Terminated
Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f)…
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?
17 of 17 products
| # | Product as published |
|---|---|
| 1 | 1006-9300-000 |
| 2 | 1006-9305-000 |
| 3 | 1006-9118-000 |
| 4 | 1006-9112-000 |
| 5 | 1006-9113-000 |
| 6 | 1006-9020-000 |
| 7 | 1006-9033-000 |
| 8 | 1006-9117-000 |
| 9 | 1006-9119-000 |
| 10 | 1006-9030-000 |
| 11 | 1006-9032-000 |
| 12 | 1006-9022-000 |
| 13 | To be provided |
| 14 | 1006-9120-000 |
| 15 | 1006-9027-000 |
| 16 | 1006-9003-000 |
| 17 | 1006-9025-000 |
- Lot codes and dates
- a) 1006-9300-000 Lot/Serial NumbersAMRB00497
- b) 1006-9305-000 Lot/Serial Numbers
2,955 of 2,955 codes
AMRE01294AMRF01283AMRG01624AMRG01625AMRF02527AMRF02529AMRF02532AMRF02534AMRE02800AMRE00725AMRE01720AMRF02386AMRF02398AMRF02399AMRF02400AMRF02401AMRF02402AMRF02403AMRG02367AMRG02368AMRG02369AMRG02370AMRH00168AMRE01962AMRE01297AMRE01298AMRE01299AMRE01300AMRE01301AMRE01302AMRE01303AMRE02061AMRE02065AMRE02124AMRE01395AMRF02556AMRG02955AMRG02958AMRG03077AMRG03179AMRE00891AMRE00892AMRE00893AMRE00894AMRE01178AMRE01179AMRE01182AMRE01183AMRE01184AMRE01185AMRE01186AMRE01187AMRE01188AMRE01191AMRE01192AMRE01193AMRE01195AMRE01719AMRG00316AMRF03164
- Amount recalled
- 7168 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.
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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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