Z-2083-2016 Class II Terminated
FDA device recall Z-2083-2016 was initiated by Medtronic Navigation, Inc.-Littleton on March 17, 2016 and is designated Class II. 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 provid… The recall status is terminated (terminated April 6, 2021). Affected quantity: US - 63.
Recall Details
- Product Type
- Devices
- Report Date
- July 13, 2016
- Initiation Date
- March 17, 2016
- Termination Date
- April 6, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US - 63
Product Description
Medtronic Navigation O-arm 02 surgical x-ray imaging system
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).
Distribution Pattern
Nationwide Distribution
Code Information
model number BT-700-02000