The Recall Desk
HighFDA (Devices)·Z-2793-2020·Announced 2020-08-19

Brainlab Kick Navigation Station Recalled for Incorrect Calibration

Brainlab AG is recalling 9 Kick navigation stations due to incorrect manufacturer calibration. The units were distributed in the US and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (incorrect calibration) that poses a risk of harm, but no injuries or illnesses are reported in the source text.

Plain-English summary

Brainlab AG is recalling nine units of the BRAINLAB Kick 2 and Kick navigation stations. The recall is due to incorrect manufacturer calibration. The affected products include specific serial numbers for the navigation stations and their associated NDI cameras.

The recalled units were distributed in the United States (California, Texas, Rhode Island) and internationally to Armenia, Australia, Brazil, Bulgaria, Canada, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Mongolia, Morocco, and Spain.

Healthcare providers should stop using the affected units and contact Brainlab AG for further instructions.

The recalled product

Product
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Manufacturer
Brainlab AG
Category
Medical Device — Surgical Navigation
Hazard
Affected units
9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • KICK 2 NAVIGATION STATION
  • Serial Numbers: 0164217001-18170
  • S/N of affected NDI Camera: P7-12520 2703119001-18170
  • S/N of affected NDI Camera:P7-20938 2933119001-18170
  • S/N of affected NDI Camera:P7-21378 6171619001-18170
  • S/N of affected NDI Camera:P7-18830 8745417001-18170
  • S/N of affected NDI Camera:P7-15162 9178819001-18170
  • S/N of affected NDI Camera:P7-16025 9607118001-18170
  • S/N of affected NDI Camera:P7-13227 5469918001-18170
  • S/N of affected NDI Camera: P7-14965 KICK NAVIGATION STATION
  • Serial Number: 1190017001-18070
  • S/N of affected NDI Camera: P7-06110

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Brainlab AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Brainlab AG

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Same hazard · incorrect calibration

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