GE Vivid E9 Ultrasound Systems Recalled for Software Lockup
GE Healthcare is recalling 710 Vivid E9 ultrasound systems worldwide due to a software defect that can cause the system to slow down and lock up during critical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (system lockup during critical procedures) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 710 units of the GE Vivid E9 diagnostic ultrasound system. The recall is due to a potential safety issue involving the system's software, which may cause the device to gradually become unresponsive and eventually lock up. This issue can occur during critical procedures, requiring the scanner to be rebooted to restore functionality.
The affected systems are distributed worldwide, including in the United States and numerous international markets. The Vivid E9 is primarily intended for cardiac imaging and analysis, but also includes vascular and general radiology applications. The recall covers specific serial numbers listed in the official FDA notice.
Healthcare facilities should check their inventory for the affected serial numbers and contact GE Healthcare for instructions on how to resolve the software issue. No specific corrective action or repair timeline is detailed in the provided source text.
The recalled product
- Product
- GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 710
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers: 0000000VE94166
- 0000000VE94167
- 0000000VE94170
- 0000000VE94171
- 0000000VE94172
- 0000000VE94173
- 0000000VE94174
- 0000000VE94175
- 0000000VE94176
- 0000000VE94177
- 0000000VE94178
- 0000000VE94179
- 0000000VE94180
- 0000000VE94181
- 0000000VE94182
- 0000000VE94183
- 0000000VE94184
- 0000000VE94185
- 0000000VE94186
- 0000000VE94187
Distribution
Distributed nationwide across the United States.
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