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Recall Observatory FDA recall evidence

Device product

Medtronic Navigation O-arm 02 surgical x-ray imaging system

Z-2083-2016

March 17, 2016

Class II

Product summary

Firm
Medtronic Navigation, Inc.-Littleton
Event
Event 74158
Status
Terminated
Classification
Class II
Quantity
US - 63
Official record key
device-enforcement:Z-2083-2016

Official wording

Reason: Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).

Code information: model number BT-700-02000

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).