Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 12, 2018
GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, Testes, thyroid; Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prost
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll recalled GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a g… - a moderate-severity action.
GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a g… was recalled by Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll in September 12, 2018. Reason: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.. Check the official notice for the remedy. Verify recall #Z-2985-2018 with the FDA Devices before acting.
The recall
Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll issued this moderate-severity FDA Devices recall-The system side of the power cord may break and expose the electrical conductors leading to the risk of shock..
- Moderate
- severity level
- Class II
- classification
- September 12, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2985-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2985-2018) was formally reported on September 12, 2018, with the manufacturer initiating the action on March 22, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll is listed as the recalling firm, operating out of Milwaukee, WI. Federal records list the affected scope as 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS).
The documented reason for this recall is: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico FOREIGN: Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State of Brazil, Brazil, Brunei Darussalam, Bu…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
12,426 (4,717 US; 7,709 OUS ALL PRODUCTS)
Related Recalls
6
0 from same agency
Product description
GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, Testes, thyroid; Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, Thoracic, & vascular)
Reason for recall
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2985-2018 |
| Date reported | September 12, 2018 |
| Date initiated | March 22, 2018 |
| Recalling firm | Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll |
| Firm location | Milwaukee, WI |
| Affected scope | 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS) |
| Distribution | Nationwide and Puerto Rico FOREIGN: Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State of Brazil, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2985-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, Testes, thyroid; Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, Thoracic, & vascular). Recalled by Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll. Units affected: 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS).
Why was this product recalled? ▼
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2985-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico FOREIGN: Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State of Brazil, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso, Canada, Chile, China, Colombia, Congo, The Democratic Republic of the Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, The Former Yugoslav Republic of, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2985-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 12, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.