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FDA device recall Z-1704-2015 · posted 2015-06-02 · Terminated

Recall details

Recalling firm
Siemens Medical Solutions USA, Inc
Reason for recall
A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay.
Action taken
Siemens sent an Safety Advisory Notice, dated May 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were given work around instructions to follow and informed that a software fix would be implemented to permanently resolve the issue. For further questions please call (610) 219-6300.
Root cause
Software design
Status
Terminated
Product code
LMD
Quantity affected
131
Distribution
Nationwide Distribution
Date initiated
2015-05-06
Date posted
2015-06-02
Date terminated
2016-08-17
Location
Malvern, PA

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