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Recall Observatory FDA recall evidence

Device product

Biograph mCT S(40)-4R, Model Number 10248671

Z-2331-2015

July 14, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA Inc.
Event
Event 71712
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2331-2015

Official wording

Reason: Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

Code information: SERIAL NUMBER 11073

Distribution pattern: Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.