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Recall Observatory FDA recall evidence

Device product

Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

Z-2082-2016

March 17, 2016

Class II

Product summary

Firm
Medtronic Navigation, Inc.-Littleton
Event
Event 74153
Status
Terminated
Classification
Class II
Quantity
US - 581
Official record key
device-enforcement:Z-2082-2016

Official wording

Reason: It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.

Code information: Model No. BI-700-00027 and BT-700-00028

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.