Hazard description
Natus has become aware of complaints related to certain Embletta MPR devices where the device is unable to correctly format its internal memory. When the internal memory cannot be correctly formatted, previously recorded studies may remain on the device and may be updated with incorrect patient information from a subsequent study. The issue may also prevent studies from initiating recording successfully or may cause recordings to end prematurely, resulting in incomplete or unavailable diagnostic data and the potential need to repeat a patient study. In some cases, users may be unable to download previously recorded studies from the device. Customers are unable to correct the memory formatting issue through normal device operation, and there is currently no workaround available. These conditions may increase the risk of incorrect patient information being associated with a study, loss of diagnostic data, delays in diagnosis, or the need to repeat patient testing.
RecallTracker