| Reason for the Action |
Quantum OPS Adaptable Beach Chair Positioning Kits may be affected by a fracture of a welded joint below the patient headrest. The affected welded joint provides structural support for the patient headrest. The potential consequences include loss of head support, unintended patient movement, disruption to airway management, interruption to the surgical procedure and/or disruption to surgical workflow.
Fracture of the welded joint supporting the patient headrest may result in partial or complete loss of head support and/or unintended movement of the headrest during a surgical procedure. This may result in patient movement, disruption to airway management, interruption or delay to the surgical procedure, and, in the worst case, patient injury associated with loss of head support or compromised airway management.
This recall does not affect any other Quantum Ops products. |