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Kit, Aurora FG Mounting Brackets, RT

Mediview Xr, Inc. · Model XR90-BRK-FG-RT · UDI-DI 00850044606047

BWN Prescription
10
510(k) clearances
225
Adverse events (1 deaths)
75
Recalls
153
Facilities

Description

The Field Generator Brackets are reusable devices that are used to attach and secure medical equipment, such as an electromagnetic field generator, to the underside of a compatible operating table for use during procedures performed with such equipment.

Recalls

DateFirmReason
2026-07-24QUANTUM OPS IncDue to a manufacturing issue (inadequate weld) for patient head positioning system.
2021-09-13Innovative Orthopedic Technologies, LLCDue to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.