Brainlab AG: BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011

Recall number

Z-2792-2020

Recalling firm

Brainlab AG

Product

BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011

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

18 units

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

CURVE 1.1 DUAL NAVIGATION STATION, Serial Numbers:  3911619001-19901, S/N of affected NDI Camera: P7-21527  1173019001-19901B, S/N of affected NDI Camera: P7-21173  1444519001-19901B, S/N of affected NDI Camera: P7-21183  1937319001-19901B, S/N of affected NDI Camera: P7-21325  2201419001-19901B, S/N of affected NDI Camera: P7-21324  2456219001-19901B, S/N of affected NDI Camera: P7-21382  3524219001-19901B, S/N of affected NDI Camera: P7-21414  5379420001-19901B, S/N of affected NDI Camera: P7-21830  5609520001-19901B, S/N of affected NDI Camera: P7-21892  6968320001-19901B, S/N of affected NDI Camera: P7-20390  4593720001-19901B, S/N of affected NDI Camera: P7-21655  7850820001-19901B, S/N of affected NDI Camera : P7-22083  6393920001-19901B, S/N of affected NDI Camera: P7-21895  3844314001-19901B, S/N of affected NDI Camera: P7-21449   CURVE DUAL DISPLAY NAVIGATION STATION, Serial Numbers:  0824912001-19900, S/N of affected NDI Camera: P7-21890  3894613001-19900, S/N of affected NDI Camera: P7-21780  4387415001-19900, S/N of affected NDI Camera:P7-07290  CURVE SINGLE DISPLAY NAVIGATION STATION, Serial Number: 5762713001-19905, S/N of affected NDI Camera: P7-10719

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

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

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