Lack of Processing Controls (lack of assurance of conformity to specifications).
All Recalls
95,025 total recalls in our database
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Breaking at the point of a welded joint
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm.
Breaking at the point of a welded joint
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Shanghai United Imaging Healthcare Co.
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Breaking at the point of a welded joint
There are reports of the suction catheter coming apart from the device assembly during use.