Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-09-29 | NAI | No action indicated | GE Medical Systems, LLC | 0 |
| 2018-06-14 | VAI | Voluntary action indicated | GE Medical Systems, LLC | 0 |
| 2016-10-11 | NAI | No action indicated | GE MEDICAL SYSTEMS, LLC | 0 |
| 2014-11-10 | NAI | No action indicated | GE Medical Systems, LLC | 0 |
| 2014-02-28 | VAI | Voluntary action indicated | GE Medical Systems, LLC | 1 |
| 2013-06-17 | VAI | Voluntary action indicated | GE Medical Systems, LLC | 1 |
| 2012-10-11 | NAI | No action indicated | GE Medical Systems, LLC | 0 |
| 2012-03-02 | VAI | Voluntary action indicated | GE Medical Systems, LLC | 7 |
| 2011-01-11 | VAI | Voluntary action indicated | GE Medical Systems, LLC | 3 |
| 2010-04-26 | NAI | No action indicated | GE Medical Systems, LLC | 0 |
| 2010-01-29 | NAI | No action indicated | GE Medical Systems, LLC | 0 |
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