Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.
Showing 401–420 of 1,000 recalls
F & A Foundation
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Beckman Coulter Inc.
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.