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 |
|---|---|---|---|---|---|---|
| 2025-09-26 | Z-0455-2026 | Class II | Open, Classified | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.Distribution: Worldwide - US Nationwide distribution. | 7408 | code info di |
Regulatory clearances
- 510(k)K253277Substantially equivalent (SESE) · 2026-07-24clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2018-07-19 | VAI | Voluntary action indicated | GE Medical Systems Information Technologies, Inc. | 5 |
| 2016-04-28 | NAI | No action indicated | GE Medical Systems Information Technologies | 0 |
| 2013-09-25 | VAI | Voluntary action indicated | GE Medical Systems Information Technologies, Inc. | 5 |
| 2013-05-14 | VAI | Voluntary action indicated | GE Medical Systems Information Technologies | 0 |
| 2012-10-09 | VAI | Voluntary action indicated | GE Medical Systems Information Technologies, Inc. | 6 |
| 2010-08-20 | NAI | No action indicated | GE Medical Systems Information Technologies, Inc. | 0 |
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