GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for ca
FDA device recall Z-0373-2014 · posted 2013-11-21 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up, with the result that the vivid E9 Scanner must be rebooted.
- Action taken
- An Urgent Medical Device Correction letter, dated 10/11/2013, was sent to 3 departments within the affected hospitals. The letter described the safety issue, and identified affected devices. The letter stated to reboot the scanner in an unresponsive /lock up condition. Also if the system is being used for an interventional procedure, the TEE probe should remain in the patient while system is rebooting. A GE healthcare service engineer will install a correction to affected devices.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 710
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germa
- Date initiated
- 2013-10-11
- Date posted
- 2013-11-21
- Date terminated
- 2015-01-23
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K120201) | Ge Vingmed Ultrasound AS | 2012-04-19 |