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Recall Observatory FDA recall evidence

Device product

Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,

Z-2071-2014

May 22, 2014

Class III

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 68353
Status
Terminated
Classification
Class III
Quantity
6 systems
Official record key
device-enforcement:Z-2071-2014

Official wording

Reason: RAPIDComm¿ 5.0 Screen Layout will display incorrect test names

Code information: Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194

Distribution pattern: Worldwide Distribution - US including the states of OR and PA., and the countries of Denmark and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    RAPIDComm¿ 5.0 Screen Layout will display incorrect test names