The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.
Allen Medical Systems
6 recalls • • Categories: Surgical Instruments, Implants & Prosthetics, Other Medical Devices
Class I - Dangerous
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Class I - Dangerous
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery.
Class I - Dangerous
During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to the patient. This potential defect is not apparent to the user.
Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall.