(b)(4) - product quality issue associated with an inherent device and/or device component characteristic that is not satisfactory as specific or delivered.Siemens healthcare diagnostics inc.Conducted a field correction, internal number (b)(4).A written customer notification was sent on 06/2014 to all customers affected notifying them of the springs contained in the access door hinge assembly on the walkaway plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customer.The notification also includes actions to be taken by customers.The fda san francisco district office was notified on 06/09/2014 of the remedial action (report no.2919016-06/09/14-001-c).A siemens representative will contact the customer over the next few months to schedule a visit to correct this issue with the access door hinge.
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