Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-0...
FDA Device Recall #Z-0114-2020 — Class II — July 19, 2019
Recall Summary
| Recall Number | Z-0114-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 19, 2019 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 502 devices |
Product Description
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
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.
Distribution Pattern
Worldwide
Lot / 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:
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.