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 |
|---|---|---|---|---|---|---|
| 2022-08-12 | Z-0182-2023 | Class II | Open, Classified | Due to un-commanded movement of mobile x-ray unit.Distribution: U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX O.U.S.: N/A | 155 systems | code info di |
Regulatory clearances
- 510(k)K192936Substantially equivalent (SESE) · 2019-11-15clearance family
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 |
|---|---|---|---|---|
| 2025-01-24 | OAI | Official action indicated | SEDECAL SA | 4 |
| 2013-06-28 | VAI | Voluntary action indicated | SEDECAL SA | 2 |
| 2010-01-15 | NAI | No action indicated | SEDECAL SA | 0 |
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