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
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2010-10-01 | Z-2897-2011 | Terminated | Toshiba America Medical Systems, Inc. is initiating a field correction on the Aplio Artida Ultrasound Diagnostic System because the panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to display patient information (heart rate, time, VCP counter, ect.). | — | clearance family | |
| 2010-09-28 | Z-1498-2011 | Terminated | Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues. | — | clearance family | |
| 2010-04-20 | Z-2179-2011 | Terminated | There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely. | — | clearance family | |
| 2010-01-06 | Z-2203-2011 | Terminated | Toshiba America Medical Systems (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in incorrect values. | — | clearance family |
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2014-09-19 | NAI | No action indicated | Canon Components, Inc. (Factory Site) | 0 |
| 2014-09-17 | NAI | No action indicated | Canon Inc. | 0 |
| 2014-09-17 | NAI | No action indicated | Canon Inc. | 0 |
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