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Recall Observatory FDA recall evidence

Device product

SOMATOM Perspective, Computed tomography x-ray system

Z-0921-2017

November 22, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 75860
Status
Terminated
Classification
Class II
Quantity
13 systems
Official record key
device-enforcement:Z-0921-2017

Official wording

Reason: Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.

Code information: Model # 10967888 Serial Number:59376 91766 91767 115456 115454 59380 77560 98840 77557 91758 59377 59378 115451

Distribution pattern: Distributed to: IL IL GA SC SD OK NY MI IN MD AR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.