Medtronic Navigation, Inc.-Littleton: Medical Device Recall in 2016 - (Recall #: Z-2083-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 17, 2016

Date Posted: July 13, 2016

Recall Number: Z-2083-2016

Event ID: 74158

Reason for Recall:

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).

Status: Terminated

Product Quantity: US - 63

Code Information:

model number BT-700-02000

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated