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BR Surgical, LLC

BR Surgical, LLC · Model BR900-2153HLS · UDI-DI 00840183507763

FCW
10
510(k) clearances
2,996
Adverse events (1 deaths)
5
Recalls
63
Facilities

Description

Halogen 150 watt Light Source w/ 4 port turret

Recalls

DateFirmReason
2023-03-02Stryker CorporationFiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
2011-10-14Integra LifeSciences Corp.A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
2011-10-14Integra LifeSciences Corp.A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
2011-10-14Integra LifeSciences Corp.A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
2011-03-07Integra LifeSciences Corp.Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.

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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.