GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
FDA device recall Z-1488-2014 · posted 2014-04-23 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction" letter dated March 27, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Managers of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact your local GE Healthcare service representative).
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 447 (81US, 366 OUS)
- Distribution
- USA Nationwide Distribution in the states of: CA, CO EL, GA, IN, KS, KY , LA, MA, MI, MO, MT, NY, NM, NV, US: OH, TX, VA, WI. OUS: ARABIC EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, COLOMBIA, CZECH REPUBLI
- Date initiated
- 2014-03-27
- Date posted
- 2014-04-23
- Date terminated
- 2015-01-14
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K131514) | Ge Vingmed Ultrasound AS | 2013-07-12 |