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 |
|---|---|---|---|---|---|---|
| 2013-11-21 | Z-0633-2014 | Class II | Terminated | Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.Distribution: Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Lithuania, Luxemborg, Mexico, Malaysia, Mozambique, Namibia, Netherlands, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Sierra Leone, El Salvador, Thailand, Turkey, Uganda, Vietnam, Kosovo, and South Africa. | 6003 units total (1715 units in the US and 4288 outside the US) | clearance family |
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-01-09 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 1 |
| 2023-08-17 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 1 |
| 2018-07-19 | NAI | No action indicated | Welch Allyn, Inc. | 0 |
| 2015-06-10 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 3 |
| 2014-08-13 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 1 |
| 2012-10-19 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 0 |
| 2012-06-25 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 7 |
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