Reported Dec 25, 2019 · Terminated
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077…
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?
14 of 14 products
| # | Product as published |
|---|---|
| 1 | 1006-9310-000 |
| 2 | 1006-9110-000 |
| 3 | 1006-9023-000 |
| 4 | 1006-9028-000 |
| 5 | 1006-9310-000-305077 |
| 6 | 1006-9310-000-015243 |
| 7 | 1006-9310-000-017602 |
| 8 | 1006-9310-000-103785 |
| 9 | 1006-9310-000-025109 |
| 10 | 1006-9310-000-009650 |
| 11 | 1006-9310-000-015224 |
| 12 | 1006-9310-000-031881 |
| 13 | 1006-9310-000-031854 |
| 14 | 1006-9310-000-026571 |
- Lot codes and dates
- a) 1006-9310-000 Lot/Serial Numbers
AMTE00190AMTH00218AMTE00125AMTE00126AMTE00118AMTG00102AMTF00224AMTG00108
- b) 1006-9110-000 Lot/Serial Numbers
87 of 87 codes
AMTG00211AMTG00149AMTF00152AMTH00115AMTH00172AMTH00108AMTF00127AMTH00125AMTF00128AMTF00189AMTH00100AMTG00111AMTH00210AMTG00178AMTG00199AMTF00126AMTF00153AMTG00113AMTH00134AMTF00168AMTH00114AMTG00177AMTF00211AMTF00166AMTF00197AMTF00143AMTG00156AMTG00115AMTE00221AMTF00125AMTG00146AMTG00167AMTG00179AMTG00190AMTH00193AMTH00194AMTF00167AMTF00141AMTH00116AMTG00169AMTG00159AMTG00212AMTG00213AMTF00144AMTG00112AMTH00126AMTG00166AMTG00155AMTF00165AMTE00222AMTF00210AMTE00225AMTG00197AMTG00148AMTH00118AMTH00133AMTF00142AMTF00129AMTH00190AMTE00227
- c) 1006-9023-000 Lot/Serial Numbers
AMTE00239AMTF00120AMTE00155AMTH00183AMTH00144AMTF00123AMTF00190AMTE00158AMTG00136AMTD00108AMTD00105AMTF00121AMTD00122AMTE00220AMTE00159AMTG00138AMTE00157AMTE00156AMTF00122AMTF00124AMTG00137AMTD00110AMTF00192AMTD00109
- d) 1006-9028-000 Lot/Serial NumbersAMTF00170 e) 1006-9310-000-305077
- Lot/Serial NumbersAMTT00236 f) 1006-9310-000-015243
- Lot/Serial NumbersAMTL00106 g) 1006-9310-000-017602
- Lot/Serial NumbersAMTR00110 AMTL00285 AMTP00299 AMTL00194 h) 1006-9310-000-103785
- Lot/Serial NumbersAMTR00120 I) 1006-9310-000-025109
- Lot/Serial NumbersAMTM00216 AMTM00196 j) 1006-9310-000-009650
- Lot/Serial NumbersAMTK00152 k) 1006-9310-000-015224
- Lot/Serial NumbersAMTL00102 l) 1006-9310-000-031881
- Lot/Serial NumbersAMTN00100 AMTN00101 m) 1006-9310-000-031854
- Lot/Serial NumbersAMTN00211 n) 1006-9310-000-026571
- Lot/Serial Numbers—
- a) 1006-9310-000 Lot/Serial Numbers
- Amount recalled
- 502 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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