FDA Medical Device Recalls (openFDA)
Brainlab AG: BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
- Recall number
- Z-2793-2020
- Recalling firm
- Brainlab AG
- Product
- BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
- Status
- Terminated
- Initiated
- 2020-07-16
- Posted
- not on file
- Terminated
- 2021-07-27
- Reason
- Incorrect manufacturer calibration
- Root cause
- Process control
- Action
- 1. Refer to the appendix for the list of Brainlab Curve or Kick Navigation Systems with an affected camera installed to determine if your navigation system is affected. 2. For Cranial or ENT navigation software in combination with an affected system camera installed: Do not use the Z-touch Laser Pointer for patient registration. Use other instruments with the standard instrument pivoting method for Surface Matching or Landmark Registration, or Automatic Image Registration (AIR) if available. 3. Please continue to follow the instructions and warnings as described in the user guide. Especially relevant is the following warning, in addition to the instructions on the registration verification page appearing in the Cranial or ENT software: Verify accuracy at multiple anatomical landmarks, especially in the region of interest, as it may differ from the accuracy verified on the skin surface. If the region of interest is not accessible, verify in areas as close as possible to the region of interest. 4. In order to avoid nuisance with Spine & Trauma 3D or Orthopedic Navigation software in combination with an affected system camera installed: Do not attempt to use the optional Disposable Clip-On Remote Control. For patient registration, acquire registration points with the standard instrument pivoting method; or for Spine & Trauma 3D use Automatic Image Registration (AIR) if available.
- Quantity
- 9 unit
- Distribution
- USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K183605"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3002619595
- Firm city
- Munich
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28