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U.S. Department of Health and Human Services

Class 2 Device Recall Aestiva MRI

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  Class 2 Device Recall Aestiva MRI see related information
Date Initiated by Firm July 19, 2019
Create Date December 17, 2019
Recall Status1 Open3, Classified
Recall Number Z-0114-2020
Recall Event ID 83425
510(K)Number K050055  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product 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
f) 1006-9310-000-015243
g) 1006-9310-000-017602
h) 1006-9310-000-103785
I) 1006-9310-000-025109
j) 1006-9310-000-009650
k) 1006-9310-000-015224
l) 1006-9310-000-031881
m) 1006-9310-000-031854
n) 1006-9310-000-026571
Code Information a) 1006-9310-000 Lot/Serial Numbers:  AMTE00190 AMTH00218 AMTE00125 AMTE00126 AMTE00118 AMTG00102 AMTF00224 AMTG00108  b) 1006-9110-000 Lot/Serial Numbers:  AMTG00211 AMTG00149 AMTF00152 AMTH00115 AMTH00172 AMTH00108 AMTF00127 AMTH00125 AMTF00128 AMTF00189 AMTH00100 AMTG00111 AMTH00210 AMTG00178 AMTG00199 AMTF00126 AMTF00153 AMTG00113 AMTH00134 AMTF00168 AMTH00114 AMTG00177 AMTF00211 AMTF00166 AMTF00197 AMTF00143 AMTG00156 AMTG00115 AMTE00221 AMTF00125 AMTG00146 AMTG00167 AMTG00179 AMTG00190 AMTH00193 AMTH00194 AMTF00167 AMTF00141 AMTH00116 AMTG00169 AMTG00159 AMTG00212 AMTG00213 AMTF00144 AMTG00112 AMTH00126 AMTG00166 AMTG00155 AMTF00165 AMTE00222 AMTF00210 AMTE00225 AMTG00197 AMTG00148 AMTH00118 AMTH00133 AMTF00142 AMTF00129 AMTH00190 AMTE00227 AMTG00147 AMTG00201 AMTG00175 AMTF00169 AMTF00212 AMTG00165 AMTF00154 AMTG00145 AMTF00203 AMTH00119 AMTF00151 AMTH00117 AMTG00168 AMTG00176 AMTF00150 AMTF00209 AMTH00186 AMTF00140 AMTF00108 AMTE00223 AMTH00132 AMTG00158 AMTH00107 AMTF00183 AMTG00114 AMTG00200 AMTG00198  c) 1006-9023-000 Lot/Serial Numbers:  AMTE00239 AMTF00120 AMTE00155 AMTH00183 AMTH00144 AMTF00123 AMTF00190 AMTE00158 AMTG00136 AMTD00108 AMTD00105 AMTF00121 AMTD00122 AMTE00220 AMTE00159 AMTG00138 AMTE00157 AMTE00156 AMTF00122 AMTF00124 AMTG00137 AMTD00110 AMTF00192 AMTD00109  d) 1006-9028-000 Lot/Serial Numbers:  AMTF00170  e) 1006-9310-000-305077 Lot/Serial Numbers:  AMTT00236  f) 1006-9310-000-015243 Lot/Serial Numbers:  AMTL00106  g) 1006-9310-000-017602 Lot/Serial Numbers:  AMTR00110 AMTL00285 AMTP00299 AMTL00194  h) 1006-9310-000-103785 Lot/Serial Numbers:  AMTR00120  I) 1006-9310-000-025109 Lot/Serial Numbers:  AMTM00216 AMTM00196  j) 1006-9310-000-009650 Lot/Serial Numbers:  AMTK00152  k) 1006-9310-000-015224 Lot/Serial Numbers:  AMTL00102  l) 1006-9310-000-031881 Lot/Serial Numbers:  AMTN00100 AMTN00101  m) 1006-9310-000-031854 Lot/Serial Numbers:  AMTN00211   n) 1006-9310-000-026571 Lot/Serial Numbers:    
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software in the Use Environment
Action The firm sent an urgent medical device correction notice to their consignees by letter on 07/19/2019. The letter explained the issue and requested that the consignee ensure that the devices are connected to a sufficiently secure terminal server.
Quantity in Commerce 502 devices
Distribution Worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA, INC.
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